Medical Device Certifications & Regulatory Requirements

Purpose

Specifies requirements for a quality management system for organizations that need to show they can consistently provide medical devices and related services that meet customer and applicable regulatory requirements.

Who it applies to

Organizations involved in one or more lifecycle stages: design and development, production, storage and distribution, installation, servicing, and suppliers of components or services to them.

Applicable products

All medical device types, including IVDs and software. Organizations may exclude certain clauses (e.g. design) only where justified and allowed by the standard and applicable regulations.

General requirements

• Documented QMS with quality manual, procedures and controlled records
• Management responsibility, resources and competence
• Risk-based approach to QMS processes and product realization
• Design and development controls (where applicable)
• Purchasing and supplier controls
• Production and process control, including validation of special processes (e.g. sterilization)
• Identification and traceability (heightened for implantables)
• Feedback, complaint handling, reporting to regulators, and corrective and preventive action (CAPA)

Typical documentation

• Quality manual and procedures
• Medical device file(s) per device type or family
• Records of design, production, inspection and CAPA
• Supplier evaluation records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Organizations implement the QMS; a certification body (accredited for ISO 13485) may audit and certify it. Regulators may audit against ISO 13485 plus their own requirements (e.g. via MDSAP).

Important notes

• ISO 13485 is a QMS standard, not a product standard; certification does not authorize sale of any device.
• It is voluntary in itself, but regulators use it: EN ISO 13485:2016 (with A11:2021) is listed as a harmonised standard under the EU MDR; FDA's Quality Management System Regulation (21 CFR Part 820, effective 2 February 2026) incorporates ISO 13485:2016 by reference; Health Canada requires an MDSAP-issued ISO 13485 certificate for Class II-IV device licences.
• ISO 13485 is a stand-alone standard; it is based on the earlier ISO 9001 structure and is not simply 'ISO 9001 plus'. An ISO 9001 certificate does not satisfy ISO 13485.
• ISO 13485:2016 was reviewed and confirmed by ISO in 2025; no amendment is listed on the ISO catalogue page.
• Implementation guidance exists (ISO 13485 handbook; ISO/TS guidance) but is not part of the requirements.

Purpose

Specifies terminology, principles and a process for managing risks associated with medical devices so manufacturers can identify hazards, estimate and evaluate risks, control them and monitor the effectiveness of controls.

Who it applies to

Medical device manufacturers across the whole lifecycle, from design through production and post-production.

Applicable products

All medical devices, including software as a medical device and IVDs. It does not set acceptable risk levels; the manufacturer defines risk acceptability criteria.

General requirements

• Risk management plan and policy for risk acceptability criteria
• Hazard identification and identification of hazardous situations
• Risk estimation and risk evaluation
• Risk control measures and verification of their effectiveness
• Evaluation of overall residual risk and benefit-risk where needed
• Risk management review before release
• Production and post-production information collection and review

Typical documentation

• Risk management plan
• Risk management file (hazard analysis, risk controls, verification)
• Risk management report

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applied by the manufacturer within its QMS; reviewed by notified bodies, auditors and regulators as part of technical documentation and QMS audits. There is no separate 'ISO 14971 certificate' in common regulatory use.

Important notes

• Voluntary in itself; EN ISO 14971:2019 (with A11:2021) is listed as a harmonised standard under the EU MDR, and FDA lists ISO 14971 as a recognized consensus standard.
• Guidance on applying it is in ISO/TR 24971 (a technical report, not requirements).
• Risk management is referenced by many other standards (IEC 60601-1, IEC 62304, IEC 62366-1, ISO 10993-1).

Purpose

Specifies requirements for a quality management system for any organization that wants to show it consistently provides products and services meeting customer and applicable requirements and aims to enhance customer satisfaction.

Who it applies to

Any organization of any size or sector, including distributors, logistics providers and component suppliers in the device supply chain.

Applicable products

Not specific to medical devices.

General requirements

• Context of the organization and interested parties
• Leadership and quality policy
• Risk-based thinking and planning
• Support, operation, performance evaluation and improvement (Plan-Do-Check-Act)

Typical documentation

• Documented information required by the standard and determined necessary by the organization

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Organizations may be certified by accredited certification bodies; transition rules for the 2026 edition are set by accreditation bodies/IAF.

Important notes

• Difference from ISO 13485: ISO 9001 emphasizes customer satisfaction and continual improvement across any sector; ISO 13485 emphasizes regulatory requirements, documentation, risk management, process validation, traceability and maintaining QMS effectiveness for medical devices.
• An ISO 9001 certificate does not meet medical device regulatory QMS requirements on its own.
• ISO 9001:2026 was published and ISO 9001:2015 (and its Amd 1:2024) withdrawn on 2026-09-16 according to the ISO catalogue.
• Many companies hold both certificates; ISO 13485 is not a subset of the 2015/2026 ISO 9001 structure.

Purpose

Specifies symbols, with their meanings and requirements for use, for conveying information supplied with medical devices, so information can be understood across languages and markets.

Who it applies to

Manufacturers and labelling teams preparing labels, packaging and accompanying documents.

Applicable products

Medical devices marketed internationally; symbols specified in other standards are excluded from its scope.

General requirements

• Use symbols as specified, with defined meanings
• Meet any requirements for use stated for each symbol
• Provide explanatory information where the target market requires it

Typical documentation

• Label artwork and symbol glossary where used

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

No certification; symbols are reviewed as part of labelling review during conformity assessment or market authorization.

Important notes

• Amendment ISO 15223-1:2021/Amd 1:2025 adds a defined term for authorized representative and makes the authorized representative symbol not specific to any country or region.
• EN ISO 15223-1:2021 and EN ISO 15223-1:2021/A1:2025 appear on the European Commission's summary list of MDR harmonised standards; a previous reference keeps presumption of conformity for a transition period (reported to 17 June 2031).
• Using a symbol does not remove a market's legal labelling requirements; some markets require text alongside symbols.
• ISO catalogue shows the standard under systematic review (stage 90.20, 2026-07-15).

Purpose

Sets common baseline requirements for information supplied by the manufacturer, so product- and group-specific standards can build on it.

Who it applies to

Device manufacturers and staff working on design, labelling, regulatory compliance and quality management.

Applicable products

Medical devices and accessories. It does not prescribe the means or format of delivery; product-specific standards take precedence where they conflict, and regulators may impose different requirements.

General requirements

• Device identification and manufacturer information
• Label and packaging information
• Accompanying information, including instructions for use where needed
• Consideration of the applicable regulatory policy ('applicable policy' concept in the 2026 edition)

Typical documentation

• Labels, packaging artwork and IFUs
• Labelling specifications linked to risk management

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

No certification; content is reviewed as part of technical documentation and labelling review by regulators or notified bodies.

Important notes

• ISO 20417:2026 (Edition 2) was published in March 2026 and replaces ISO 20417:2021, which ISO lists as withdrawn on 2026-03-17.
• The 2026 edition is a technical revision with revised normative references, removal of several informative annexes and a new 'applicable policy' concept (per the ISO catalogue page).
• EN ISO 20417 does not appear on the European Commission's MDR harmonised standards summary list checked for this entry, so it does not currently confer a presumption of conformity in the EU; it can still be used as a state-of-the-art reference.
• It replaced EN 1041 as the general labelling standard in Europe at the 2021 edition, according to secondary sources.

Purpose

Defines requirements for the basic safety and essential performance of medical electrical equipment and systems, covering hazards such as electric shock, mechanical, radiation, fire and programmable system risks.

Who it applies to

Manufacturers of mains- or battery-powered medical electrical equipment and medical electrical systems, and test laboratories.

Applicable products

Medical electrical equipment (e.g. electrosurgical generators, monitors, imaging systems, powered surgical tools). It does not apply to non-powered instruments such as manual forceps, scissors or retractors.

General requirements

• General standard IEC 60601-1: basic safety and essential performance, with risk management linked to ISO 14971
• Collateral standards (IEC 60601-1-x) for horizontal topics, e.g. EMC (60601-1-2), usability (60601-1-6), alarms (60601-1-8), home healthcare (60601-1-11)
• Particular standards (IEC 60601-2-x and some -3-x) that modify or add to general requirements for specific equipment types; where one applies, it takes priority
• Programmable electrical medical system (PEMS) requirements, linked to software lifecycle standards

Typical documentation

• Test reports (often in the IECEE CB scheme format)
• Risk management file
• Accompanying documents and markings required by the standard

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Usually tested by a third-party or accredited laboratory; results support regulatory submissions. Some regulators accept declarations of conformity to recognized editions.

Important notes

• The IEC states the general standard should not be used alone where a collateral or particular standard applies.
• Voluntary in itself; EN 60601-1:2006 with amendments (including A13:2024) appears on the EU MDR harmonised standards list, and FDA recognizes IEC 60601-1 and many parts.
• Current consolidated general standard: IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Edition 3.2), stability date 2028 on the IEC Webstore.
• Editions accepted by regulators can lag IEC publications; check each market.

Purpose

Specifies lifecycle requirements for the development and maintenance of medical device software, providing a framework of processes, activities and tasks.

Who it applies to

Manufacturers developing software that is itself a medical device or is embedded in or part of a medical device.

Applicable products

Software in or as medical devices. It does not cover validation and final release of the medical device as a whole.

General requirements

• Software development planning
• Software safety classification (Class A, B, C) determining rigour
• Requirements, architecture, detailed design, implementation, integration and system testing
• Software risk management linked to ISO 14971
• Software configuration management and problem resolution
• Software maintenance, including management of software of unknown provenance (SOUP)

Typical documentation

• Software development plan
• Software requirements and architecture
• Verification records
• Configuration and problem-resolution records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applied within the manufacturer's QMS; evidence is reviewed in technical documentation, premarket submissions and audits.

Important notes

• Current publication: IEC 62304:2006+AMD1:2015 (consolidated), stability date 2028 on the IEC Webstore.
• Voluntary in itself; FDA lists IEC 62304 as a recognized consensus standard. EN 62304 did not appear on the European Commission's MDR harmonised standards summary list checked, though it is widely used as state of the art.
• It does not address cybersecurity in depth; see IEC 81001-5-1.

Purpose

Specifies a process for manufacturers to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety, so risks from normal use and use errors are assessed and reduced.

Who it applies to

Manufacturers of medical devices with user interfaces, including labels, controls, displays, software and IFUs.

Applicable products

Applicable broadly to devices with user interaction; it does not address abnormal use.

General requirements

• Use specification (intended users, use environments, user interface)
• Identification of user-interface characteristics related to safety and potential use errors
• Identification of hazard-related use scenarios
• User interface specification and evaluation plan
• Formative evaluation and summative evaluation of safety-related usability

Typical documentation

• Usability engineering file
• Evaluation plans and reports
• Links to the risk management file

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applied by the manufacturer and reviewed in technical documentation and premarket submissions.

Important notes

• Current publication: IEC 62366-1:2015+AMD1:2020 (consolidated Edition 1.1), stability date 2028.
• IEC TR 62366-2 provides guidance (not requirements).
• Regulators may also have their own human-factors guidance (e.g. FDA) that is not identical to the standard.

Purpose

Defines lifecycle requirements for development and maintenance of health software that support security, building on the IEC 62443-4-1 secure development approach and balancing safety, effectiveness and security.

Who it applies to

Manufacturers of health software, including software in or as medical devices and connected medical devices.

Applicable products

Health software and software in connected devices; it does not specify the content of accompanying documentation.

General requirements

• Security requirements within the software development process
• Security risk management
• Secure design, implementation, verification and vulnerability testing
• Software configuration management
• Software problem resolution and vulnerability handling after release

Typical documentation

• Security plan and security risk assessment
• Threat models and test evidence
• Vulnerability handling records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applied by the manufacturer within its lifecycle processes; evidence supports regulatory cybersecurity expectations in premarket submissions.

Important notes

• Published 2021-12-16 as Edition 1.0; IEC notes Interpretation Sheet 1 (2025-12).
• Voluntary in itself; regulators publish their own cybersecurity guidance and requirements that may go beyond it.
• Complements, rather than replaces, IEC 62304 and ISO 14971.

Purpose

ISO 10993-1 specifies requirements and general principles for the biological evaluation of medical devices within a risk management process according to ISO 14971; other parts give specific test methods and evaluation approaches.

Who it applies to

Manufacturers of devices with direct or indirect contact with the patient's body, and testing laboratories.

Applicable products

Devices contacting the body during intended use or reasonably foreseeable misuse (e.g. surgical instruments, implants, dental materials), plus certain personal protective items in scope of Part 1. Devices with no body contact may not need biological evaluation.

General requirements

• Biological evaluation plan within the risk management process
• Device categorisation by nature and duration of body contact
• Material and chemical characterisation (ISO 10993-18)
• Identification of biological hazards and selection of endpoints
• Testing or justification for endpoints (e.g. cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity, implantation)
• Biological evaluation report and re-evaluation after changes

Typical documentation

• Biological evaluation plan and report
• Test reports from qualified laboratories
• Material and processing information

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Manufacturer leads the evaluation; testing labs (often GLP and/or ISO/IEC 17025 accredited) perform tests; regulators and notified bodies review the evaluation.

Important notes

• ISO 10993-1:2025 (Edition 6) was published in November 2025 and replaces ISO 10993-1:2018; it is restructured to align with ISO 14971 and treats biological evaluation as a continuing lifecycle activity.
• EN ISO 10993-1:2025 appears on the European Commission's MDR harmonised standards summary list.
• FDA partially recognized ISO 10993-1:2025 (May 2026), excluding some clauses, and stated it will accept declarations to the 2018 edition until 1 July 2029 (per FDA presentation and secondary summaries).
• Biological evaluation is not a checklist of tests; existing data and chemical characterisation can justify not testing certain endpoints.

Purpose

Specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices, in industrial and health care facility settings.

Who it applies to

Device manufacturers that sterilize with EO, contract sterilizers, and health care facilities using EO.

Applicable products

Medical devices labelled sterile and sterilized by EO. Not relevant to devices supplied non-sterile or sterilized by other methods.

General requirements

• Characterisation of the sterilizing agent and process
• Product definition and process definition
• Validation: installation, operational and performance qualification
• Routine monitoring and control of process parameters
• Product release from sterilization (Amd 1 revised single batch release, Annex E)
• Maintaining process effectiveness; consideration of EO residuals (ISO 10993-7)

Typical documentation

• Validation protocols and reports
• Routine batch records
• Requalification records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applied by the manufacturer and/or sterilization contractor within a QMS; sterilization validation is audited by certification bodies, notified bodies and regulators as a special process.

Important notes

• Current edition: ISO 11135:2014 with Amd 1:2018.
• ISO lists a revision (ISO/FDIS 11135, Edition 3) at FDIS ballot from 2026-09-16; a new edition may publish soon.
• EN ISO 11135:2014 and A1:2019 appear on the European Commission's MDR harmonised standards summary list.
• Separately, EO use is subject to environmental and occupational rules in many countries.

Purpose

ISO 11137-1 specifies requirements for development, validation and routine control of a radiation sterilization process; other parts cover establishing the sterilization dose (Part 2) and dosimetry guidance (Part 3).

Who it applies to

Manufacturers using radiation sterilization and contract irradiation facilities.

Applicable products

Medical devices sterilized by radiation. Not applicable to devices supplied non-sterile or sterilized by other methods.

General requirements

• Process and equipment characterisation
• Product definition and maximum acceptable dose
• Establishing the sterilization dose (ISO 11137-2 methods)
• Installation, operational and performance qualification, with dosimetry
• Routine monitoring, control and product release
• Dose audits to maintain process effectiveness

Typical documentation

• Dose setting and validation reports
• Dose mapping and dosimetry records
• Dose audit records
• Irradiation certificates per batch

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applied by the manufacturer and irradiation contractor within a QMS; audited as a special process.

Important notes

• ISO 11137-1:2025 (Edition 2) was published in April 2025 and replaces ISO 11137-1:2006 and its amendments.
• The European Commission's MDR harmonised standards summary list still references EN ISO 11137-1:2015 (based on ISO 11137-1:2006 with amendments, A2:2019); the 2025 edition was not shown as harmonised in the list checked.
• Other parts have separate editions; verify each before quoting.

Purpose

Lets an MDSAP-recognized auditing organization conduct a single regulatory audit of a medical device manufacturer's QMS that satisfies the relevant requirements of the participating regulatory authorities.

Who it applies to

Medical device manufacturers selling, or planning to sell, in one or more participating jurisdictions.

Applicable products

Covers the manufacturer's QMS for the devices in scope; it is not a product review.

General requirements

• QMS meeting ISO 13485:2016
• Additional jurisdiction-specific requirements of the participating regulators for the markets selected
• Audit by an MDSAP-recognized auditing organization

Typical documentation

• MDSAP audit reports
• MDSAP certificate (ISO 13485 certificate issued under the programme)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

An MDSAP-recognized auditing organization audits the manufacturer against ISO 13485 and the selected regulators' requirements; regulators receive and use the reports in their own processes.

Important notes

• Members (per FDA page): TGA (Australia), ANVISA (Brazil), Health Canada, MHLW and PMDA (Japan), US FDA.
• Affiliate members (per FDA page): ANMAT (Argentina), Ministry of Health of Israel, Pharmacy and Poisons Board (Kenya), MFDS (Republic of Korea), COFEPRIS (Mexico), SAHPRA (South Africa), TFDA (Taiwan).
• Official observers (per FDA page): European Union, HSA (Singapore), MHRA (UK), WHO Prequalification of IVDs programme.
• MDSAP does not replace any country's product authorization, registration or listing; each regulator still decides on marketing authorization under its own rules.
• FDA may accept MDSAP audit reports as a substitute for routine FDA inspections; firms with electronic product radiation control activities remain subject to FDA inspection for those.
• Health Canada requires an MDSAP-issued ISO 13485 certificate from a recognized auditing organization for Class II, III and IV medical device licence applications.
• How each regulator uses MDSAP reports differs; observers and affiliates do not necessarily accept MDSAP outputs in the same way as members.

Purpose

Sets common safety and performance rules for medical devices and in vitro diagnostics placed on the EU/EEA market, and the obligations of manufacturers and other economic operators across the device life cycle.

Who it applies to

Manufacturers (EU and non-EU), authorised representatives, importers, distributors and notified bodies dealing with devices placed on the EU/EEA market. Northern Ireland also applies these EU rules.

Applicable products

General medical devices and accessories (MDR) and in vitro diagnostic devices (IVDR). Some products without a medical purpose listed in MDR Annex XVI are also covered.

Classification

MDR: Class I (incl. Is sterile, Im measuring, Ir reusable surgical instruments), IIa, IIb, III. IVDR: Class A, B, C, D. Classes are set by the rules in MDR Annex VIII / IVDR Annex VIII.

General requirements

• Classify the device under the applicable Annex VIII rules.
• Meet the General Safety and Performance Requirements (Annex I).
• Follow the conformity assessment procedure for the class; a notified body is needed for all classes except Class I (non-sterile, non-measuring, non-reusable-surgical) and Class A non-sterile IVDs.
• Draw up technical documentation, an EU Declaration of Conformity and affix the CE mark.
• Operate a quality management system, post-market surveillance and vigilance, and UDI/EUDAMED registration.
• Non-EU manufacturers must designate an EU authorised representative.

Typical documentation

• Technical documentation (Annexes II and III)
• EU Declaration of Conformity
• Clinical evaluation (MDR) or performance evaluation (IVDR)
• Labelling and instructions for use
• Notified body certificates where required

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Classify, implement QMS and technical documentation, complete the conformity assessment (self-declaration or notified body), sign the Declaration of Conformity, CE mark, register in EUDAMED and then maintain post-market obligations.

Important notes

• CE marking is not issued by the EU or by a notified body; the manufacturer affixes it after completing conformity assessment.
• Many devices certified under the old Directives (MDD/AIMDD) can still be placed on the market under the extended transitional provisions of Regulation (EU) 2023/607, subject to conditions.
• ISO 13485 is a harmonised route to show QMS conformity but the legal requirement is the MDR/IVDR QMS obligation itself.

Purpose

Ensures the depth of independent assessment matches the device risk before CE marking.

Who it applies to

Manufacturers placing general medical devices on the EU/EEA market under the MDR.

Applicable products

All MDR devices. Legacy devices still covered by Directive certificates under the transitional provisions follow those certificates until they move to MDR.

Classification

Class I, Is, Im, Ir, IIa, IIb, III (MDR Annex VIII, 22 rules). Under Rule 6, surgically invasive transient-use devices are IIa, but reusable surgical instruments are Class I.

General requirements

• Apply Annex VIII classification rules; if several rules apply, the strictest applies.
• Class I (not sterile, not measuring, not reusable surgical): manufacturer self-declares conformity (Annex II/III documentation, Article 52(7)).
• Class Is/Im/Ir: notified body involvement limited to sterility, metrology, or for Ir the reuse aspects (cleaning, disinfection, sterilisation, maintenance, functional testing and related instructions).
• Class IIa, IIb, III: notified body conformity assessment (typically QMS plus technical documentation assessment under Annex IX, or Annex X/XI options).
• Choose a notified body designated under the MDR for the relevant device codes (listed in the Commission NANDO database).

Typical documentation

• Classification rationale
• QMS documentation
• Technical documentation for notified body review where applicable
• Reprocessing instructions and validation evidence for reusable surgical instruments

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Determine the class, select the Annex IX-XI route allowed for that class, apply to a designated notified body where required, and obtain certificates before CE marking.

Important notes

• Reusable surgical instruments (e.g. forceps, scissors) are typically Class Ir under the MDR; the notified body assesses the reuse aspects only, not the whole device. Single-use transient surgically invasive instruments are generally Class IIa under Rule 6.
• Notified bodies are not needed for all devices; plain Class I devices are self-declared.
• A notified body certificate is device/scope specific, not a general company 'CE certificate'.

Purpose

Provides the evidence that a device is safe and performs as intended and supports the Declaration of Conformity.

Who it applies to

All manufacturers of MDR devices, including Class I self-declared devices.

Applicable products

All MDR devices; depth of clinical data depends on class, novelty and claims. Implantable and Class III devices generally need clinical investigations, subject to MDR exemptions.

Classification

Applies to all classes; notified body review of the documentation varies by class.

General requirements

• Prepare technical documentation per Annex II (device description, labelling, design and manufacturing, GSPR checklist, risk management, verification and validation).
• Prepare post-market surveillance documentation per Annex III.
• Perform and document a clinical evaluation (Article 61 and Annex XIV), updated with post-market data.
• Keep documentation available to competent authorities.

Typical documentation

• Device description and specifications
• GSPR checklist with standards applied
• Risk management file
• Biocompatibility, sterilisation/reprocessing and performance test reports where relevant
• Clinical evaluation plan and report
• Labelling and IFU

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Compile and maintain the file during design and throughout the market life; update the clinical evaluation with PMS and PMCF findings.

Important notes

• For reusable instruments, validated reprocessing instructions (cleaning, disinfection, sterilisation) are part of the evidence; EN ISO 17664 is commonly used.
• Equivalence claims must meet MDR criteria; this area is targeted by the 2025 revision proposal.

Purpose

Shows the manufacturer has completed the required conformity assessment and takes responsibility for compliance.

Who it applies to

Manufacturers of MDR and IVDR devices, except custom-made and investigational devices.

Applicable products

All devices placed on the EU/EEA market apart from custom-made devices and devices for clinical investigation/performance studies.

Classification

All classes; the notified body identification number accompanies the CE mark when a notified body took part.

General requirements

• Complete the applicable conformity assessment first.
• Draw up an EU Declaration of Conformity with the content of Annex IV, kept updated.
• Affix the CE mark visibly, legibly and indelibly on the device or packaging and IFU as required.
• Include the notified body number where applicable.

Typical documentation

• EU Declaration of Conformity
• Supporting technical documentation and certificates

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Sign the Declaration, apply the mark and keep both available for authorities.

Important notes

• There is no official EU 'CE certificate' issued to companies; marketing claims of 'CE certified company' are misleading.
• Customs, distributors and importers check for CE marking and documents.

Purpose

Gives authorities an accountable party in the EU and spreads compliance checks along the supply chain.

Who it applies to

Non-EU manufacturers, EU authorised representatives, importers and distributors of MDR/IVDR devices.

Applicable products

All MDR and IVDR devices placed on the EU/EEA market.

General requirements

• Non-EU manufacturer: designate a single EU authorised representative by written mandate (Article 11).
• Manufacturer and authorised representative: have a person responsible for regulatory compliance (PRRC) available (Article 15; micro and small enterprises may have one permanently and continuously at their disposal).
• Importer: verify CE marking, DoC, manufacturer/AR identification, labelling and UDI; add its own details to the device/packaging; register in EUDAMED (Article 13).
• Distributor: verify CE marking, labelling, IFU and importer details; keep complaint and traceability records (Article 14).
• Inform the competent authority in advance of an interruption or discontinuation of supply that could cause serious harm (Article 10a, applying from 10 January 2025).

Typical documentation

• Written mandate with the authorised representative
• Copies of DoC and certificates
• Supply chain traceability records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Appoint the AR before placing devices on the market, record actors in EUDAMED and agree responsibilities in supply contracts.

Important notes

• Exporters from outside the EU (e.g. Pakistan, India, China) cannot place devices on the EU market without an EU authorised representative.
• A distributor or importer that changes labelling or intended purpose may take on manufacturer obligations (Article 16).

Purpose

Improves traceability, transparency and recall effectiveness across the EU.

Who it applies to

Manufacturers, authorised representatives, importers and system/procedure pack producers; notified bodies for certificate data.

Applicable products

All MDR/IVDR devices other than custom-made and investigational devices; legacy devices still placed on the market must also be registered.

Classification

Applies to all classes; UDI carrier placement deadlines were phased by class under the MDR.

General requirements

• Register as an actor in EUDAMED and obtain a Single Registration Number (SRN).
• Assign Basic UDI-DI and UDI-DI through an EU-designated issuing entity and register device data in the UDI/Device module.
• Place UDI carriers on labels/packaging; reusable devices needing reprocessing must carry a UDI carrier on the device itself (with MDR transition dates by class).
• Provide label and IFU information required by MDR Annex I Chapter III, in languages required by Member States.

Typical documentation

• SRN
• UDI-DI and Basic UDI-DI records
• Labels and IFU

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Register actors, then devices, before placing new devices on the market. Commission Decision (EU) 2025/2371 (OJ 27 November 2025) declared four modules functional, triggering mandatory use six months later.

Important notes

• Mandatory since 28 May 2026: Actor registration, UDI/Device registration, Notified Bodies and Certificates, Market Surveillance.
• Vigilance/PMS and Clinical Investigation modules are not yet mandatory; vigilance reporting still follows national routes.
• Devices already on the market before mandatory use have a transition window to be registered (reported as ending late November 2026 - check the Commission timeline PDFs).

Purpose

Detects safety and performance problems after market entry and drives corrective action.

Who it applies to

All MDR/IVDR manufacturers; importers and distributors must pass on complaints and cooperate.

Applicable products

All devices on the EU market, including legacy devices under transitional provisions (MDR PMS/vigilance rules apply to them).

Classification

Class I: PMS report. Class IIa, IIb, III: periodic safety update report (PSUR) with frequency by class.

General requirements

• Plan and run PMS proportionate to risk (Articles 83-86, Annex III).
• Report serious incidents and field safety corrective actions to competent authorities (Article 87 onwards).
• Trend reporting of non-serious incidents with significant increases.
• Feed PMS results into risk management, clinical evaluation and corrective actions.

Typical documentation

• PMS plan
• PMS report or PSUR
• Vigilance records and field safety notices
• Complaint files

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Collect and analyse post-market data continuously and report incidents within the MDR timelines.

Important notes

• Until the EUDAMED vigilance module is mandatory, incident reports go to national competent authorities using the Commission's report forms.

Purpose

Avoids shortages while manufacturers move devices from the old Directives to MDR certification.

Who it applies to

Manufacturers of legacy devices with valid MDD/AIMDD certificates or declarations (including Class I devices up-classified under MDR) meeting the conditions.

Applicable products

Legacy devices only; not new devices or devices with significant changes in design or intended purpose.

Classification

31 December 2027: Class III and Class IIb implantable (with some well-established-technology exceptions). 31 December 2028: other Class IIb, IIa, and Class I devices needing a notified body under MDR.

General requirements

• Device continues to comply with the Directive and has no significant changes in design or intended purpose.
• No unacceptable risk to health or safety.
• MDR-compliant QMS in place by 26 May 2024.
• Formal application to an MDR notified body lodged by 26 May 2024, and written agreement signed by 26 September 2024.
• MDR post-market surveillance, vigilance and registration requirements apply.

Typical documentation

• Valid Directive certificate or declaration
• Evidence of NB application and written agreement
• MDR QMS documentation

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Maintain legacy compliance while completing MDR certification before the applicable end date.

Important notes

• Regulation 2023/607 also removed the 'sell-off' date for devices already placed on the market.
• Class I reusable surgical instruments self-declared under the MDD that now need NB involvement (Ir) are among the up-classified devices covered.

Purpose

Sets safety, performance and evidence rules for in vitro diagnostic devices in the EU.

Who it applies to

Manufacturers, authorised representatives, importers and distributors of IVDs placed on the EU/EEA market.

Applicable products

In vitro diagnostic medical devices and accessories; not relevant to surgical instruments.

Classification

Class A (lowest), B, C, D (highest) under IVDR Annex VIII. Class A non-sterile can be self-declared.

General requirements

• Classify under Annex VIII; Classes B, C, D and sterile Class A need notified body involvement.
• Performance evaluation (scientific validity, analytical and clinical performance).
• Technical documentation, DoC, CE marking, UDI and EUDAMED registration, PMS and vigilance.

Typical documentation

• Technical documentation
• Performance evaluation report
• DoC
• PMS documentation

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Similar to MDR: classify, choose conformity route, obtain notified body certificate where required, CE mark, register and monitor.

Important notes

• Regulation (EU) 2024/1860 extended IVDD legacy transitions: Class D to 31 Dec 2027, Class C to 31 Dec 2028, Class B and sterile Class A to 31 Dec 2029, subject to QMS and notified body application conditions.

Purpose

Provides reasonable assurance that medical devices sold in the US are safe and effective, through classification, premarket review where required, and general and special controls.

Who it applies to

Domestic and foreign establishments that manufacture, repackage, relabel, specification-develop or import devices for US distribution.

Applicable products

All medical devices including IVDs and software as a medical device. Some IVDs and blood-related devices are reviewed by CBER.

Classification

Class I (general controls), Class II (general and special controls), Class III (PMA). Class is set by the device-type classification regulation in 21 CFR Parts 862-892.

General requirements

• Find the classification regulation and product code for the device type.
• Register the establishment and list devices annually.
• Obtain marketing authorization (510(k), De Novo or PMA) unless the device type is exempt.
• Comply with QMSR (21 CFR 820), labeling (Part 801), UDI (Part 830), Medical Device Reporting (Part 803) and corrections/removals (Part 806), unless exempted.

Typical documentation

• Classification rationale (regulation number, product code)
• Premarket submission where required
• QMS records
• Labeling
• Complaint and MDR files

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Classify, choose the premarket pathway (or confirm exemption), register and list, then maintain postmarket compliance.

Important notes

• Registration and listing are not FDA clearance or approval; FDA does not issue registration 'certificates'.
• ISO 13485 certification is not a prerequisite for US market access; FDA checks compliance through inspections.

Purpose

Tells FDA where device establishments are and who is responsible, supporting inspections and import checks.

Who it applies to

Owners/operators of domestic and foreign establishments such as manufacturers, specification developers, contract manufacturers, repackagers/relabelers, and initial importers (see FDA's who-must-register table).

Applicable products

All device types, including 510(k)-exempt Class I devices such as many manual surgical instruments.

Classification

Applies regardless of device class.

General requirements

• Register electronically (FURLS/DRLM) unless a waiver is granted.
• Renew/verify registration annually between 1 October and 31 December.
• Pay the annual establishment registration fee (amount set yearly under MDUFA; small-business waiver possible for the annual fee in FY2026).
• Foreign establishments: designate one US agent with a US physical address (no PO box).

Typical documentation

• Owner/operator and establishment details
• US agent confirmation (foreign establishments)
• Fee payment confirmation

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Pay the fee, then submit registration in FURLS; repeat annually and update on changes.

Validity and renewal

Annual; registration must be renewed each year between 1 October and 31 December.

Important notes

• Registration does not mean FDA has cleared, approved or endorsed the company or its devices.
• The US agent is a communication contact; it is not responsible for adverse event reporting or marketing submissions.

Purpose

Gives FDA an inventory of devices and activities at each registered establishment.

Who it applies to

Registered establishments (domestic and foreign) for each device in commercial distribution in the US.

Applicable products

All marketed devices, including 510(k)-exempt devices, which are listed under their product code without a premarket number.

Classification

All classes.

General requirements

• List devices by product code and activity (e.g. manufacturer, contract sterilizer, relabeler).
• Provide the premarket submission number where marketing authorization was required.
• Update listings when devices or activities change, and review annually.

Typical documentation

• Product code and proprietary names
• Premarket submission number where applicable

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Completed in the same FDA electronic system as registration.

Important notes

• Listing an exempt device is not proof that it is exempt; the exemption depends on the classification regulation and its limitations.

Purpose

Lets FDA confirm, before marketing, that a new or modified device is as safe and effective as an existing legally marketed device.

Who it applies to

Domestic and foreign manufacturers, specification developers and some repackagers/relabelers introducing a non-exempt device; importers do not need their own 510(k) if the foreign manufacturer holds one.

Applicable products

Non-exempt Class I and II devices and some preamendment Class III device types; also significant changes to cleared devices or new intended uses.

Classification

Mostly Class II; some Class I and certain Class III types.

General requirements

• Identify a predicate with the same intended use.
• Show same technological characteristics, or differences that raise no new safety/effectiveness questions, with performance data.
• Submit electronically via eSTAR (required since 1 October 2023, unless exempt) at least 90 days before marketing.
• Do not market until FDA issues a substantial equivalence (clearance) order.

Typical documentation

• Device description and indications
• Predicate comparison
• Performance testing (bench, biocompatibility, sterilization, software, electrical safety as relevant)
• Proposed labeling

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Prepare eSTAR submission, pay the user fee, respond to FDA questions; FDA says the substantial equivalence decision is usually made within 90 days.

Important notes

• '510(k) cleared' is correct; '510(k) approved' or 'FDA approved' is not.
• A 510(k) is device-specific; it does not authorize other products from the same company.

Purpose

Scientific and regulatory review of high-risk devices where general and special controls alone are insufficient.

Who it applies to

Manufacturers of Class III devices that require PMA.

Applicable products

Class III devices (e.g. many life-supporting or implantable devices). Not relevant to typical manual surgical instruments.

Classification

Class III.

General requirements

• Submit non-clinical and clinical data (clinical studies under IDE where applicable).
• Non-clinical lab studies must follow 21 CFR Part 58 (GLP).
• Pay the PMA user fee.
• Manufacturing information and facility readiness for inspection.

Typical documentation

• Clinical investigation reports
• Non-clinical study reports
• Manufacturing information
• Labeling
• Form FDA 3674

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Usually preceded by Pre-Submission and IDE studies; FDA review of the application, with possible advisory panel, leads to approval or denial.

Important notes

• A Class III device without required PMA is adulterated and cannot be legally marketed.

Purpose

Provides a risk-based route to market for novel devices that would otherwise default to Class III.

Who it applies to

Manufacturers of novel devices without a legally marketed predicate, or after a 'not substantially equivalent' 510(k) decision.

Applicable products

Novel devices where general controls, or general plus special controls, can provide reasonable assurance of safety and effectiveness.

Classification

Results in Class I or Class II (with special controls) if granted.

General requirements

• Describe the device, risks and proposed controls.
• Provide performance data supporting the proposed classification.
• Submit via eSTAR (required from 1 October 2025, unless exempted).

Typical documentation

• Risk/benefit analysis
• Proposed special controls
• Performance and clinical data as needed
• Labeling

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

A Pre-Submission is recommended; FDA grants or declines the request. A granted device can serve as a predicate for later 510(k)s.

Important notes

• If declined, the device remains Class III and generally needs PMA or a new De Novo.

Purpose

Removes premarket notification for well-understood low-risk device types while keeping other controls.

Who it applies to

Manufacturers of device types whose classification regulation grants a 510(k) exemption.

Applicable products

Exemption is device-type specific and limited by the '.9' section of each part (e.g. 878.9); devices with a different intended use or different fundamental technology lose the exemption.

Classification

21 CFR 878.4800: nonpowered, hand-held or hand-manipulated reusable or disposable instruments (e.g. forceps, clamps, scalpels, retractors) for general surgery - Class I, 510(k)-exempt subject to 878.9.

General requirements

• Confirm the classification regulation and product code and its stated exemptions.
• Check the limitations of exemption (e.g. 21 CFR 878.9).
• Still register, list and meet applicable general controls (QMSR unless also exempt, labeling, UDI, MDR).

Typical documentation

• Record of classification regulation, product code and exemption rationale

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

No premarket submission when exempt; register and list before distribution.

Important notes

• Instruments with specialty uses are classified in other regulations in Parts 868-892 and may differ (e.g. dental, ophthalmic, orthopedic instruments).
• Exempt manufacturers that are also exempt from CGMP must still keep complaint files and general records (21 CFR 820.35 per FDA's QMSR page).
• '510(k)-exempt' does not mean 'unregulated'.

Purpose

Sets current good manufacturing practice/quality management requirements for finished device manufacturers, aligned with the international QMS standard.

Who it applies to

Manufacturers of finished devices for US distribution, domestic and foreign, unless the device type is exempted by its classification regulation.

Applicable products

Most devices; some classified device types are exempt from CGMP, but exempt manufacturers still keep complaint files and general records (820.35).

Classification

All classes unless exempted.

General requirements

• Implement a QMS meeting ISO 13485:2016 (incorporated by reference) and ISO 9000:2015 clause 3 definitions.
• Meet additional FDA requirements in Part 820 (e.g. records requirements in 820.35, labeling and packaging controls) and other FDA regulations; where they conflict, the FD&C Act and FDA regulations control.
• Risk management throughout product realization, as required by ISO 13485.

Typical documentation

• Quality manual and procedures
• Design and development records
• Complaint, nonconformity and CAPA records
• Device records/production records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

FDA verifies compliance through inspections under Compliance Program 7382.850 (QSIT is no longer used from 2 February 2026).

Important notes

• An ISO 13485 certificate is not required for US market access and does not replace FDA inspection.
• Devices under IDE remain subject to design and development requirements.

Purpose

Lets FDA monitor device performance and detect safety problems after marketing.

Who it applies to

Manufacturers, importers and device user facilities.

Applicable products

All marketed devices, including 510(k)-exempt devices.

Classification

All classes.

General requirements

• Manufacturers: 30-calendar-day reports for deaths, serious injuries and malfunctions likely to cause them if recurring; 5-work-day reports when FDA requests or remedial action is needed to prevent unreasonable risk of substantial harm.
• Importers: report deaths and serious injuries to FDA and the manufacturer, malfunctions to the manufacturer, within 30 calendar days.
• Manufacturers and importers submit electronically (eMDR).
• Maintain written MDR procedures and files.

Typical documentation

• MDR procedures
• MDR event files
• Form FDA 3500A / eMDR submissions

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Evaluate complaints for reportability and submit within the required time frames.

Important notes

• User facilities report deaths to FDA and manufacturer and serious injuries to the manufacturer within 10 work days.

Purpose

Ensures adequate directions for use and consistent identification for traceability, recalls and adverse event reporting.

Who it applies to

Labelers (usually manufacturers, or relabelers/repackagers) of devices distributed in the US.

Applicable products

Most devices; Part 801 Subpart B lists UDI exceptions and some Class I devices have specific exceptions. Devices intended to be reprocessed and reused need direct marking unless an exception applies.

Classification

All classes, with some exceptions in Part 801.

General requirements

• Label with name and place of business, adequate directions for use (or prescription-device labeling), and other Part 801 content.
• Obtain UDIs from an FDA-accredited issuing agency and place them in plain-text and AIDC form.
• Submit device identifier data to the Global Unique Device Identification Database (GUDID).
• Direct-mark reusable devices that are reprocessed between uses, unless an exception applies.

Typical documentation

• Label and IFU artwork
• UDI assignment records
• GUDID submissions

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Assign UDI, set up a GUDID account, submit records and apply compliant labels before distribution.

Important notes

• Reprocessing instructions for reusable instruments should be validated; FDA has guidance on reprocessing medical devices in health care settings.

Purpose

Sets the requirements for placing medical devices and IVDs on the UK market, administered by the MHRA.

Who it applies to

Manufacturers, UK Responsible Persons, importers and distributors placing devices on the market in Great Britain (England, Wales, Scotland) or Northern Ireland.

Applicable products

General medical devices, active implantables, IVDs, custom-made devices and system/procedure packs.

Classification

GB (UK MDR 2002, based on the former EU Directives): Class I, IIa, IIb, III; AIMDs; IVDs (general, self-test, List A, List B). Northern Ireland: EU MDR/IVDR classes.

General requirements

• Choose UKCA marking (UK conformity assessment) or rely on CE marking accepted in GB within the current acceptance arrangements.
• Register devices with the MHRA before placing them on the GB market.
• Non-UK manufacturers appoint a UK Responsible Person.
• Meet post-market surveillance and vigilance requirements, strengthened from 16 June 2025.

Typical documentation

• Declaration of conformity
• Technical documentation
• Approved body or notified body certificates where required
• Labelling with UKRP details where applicable

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Complete conformity assessment, apply marking, appoint UKRP if non-UK, register with MHRA, then maintain PMS and vigilance.

Important notes

• EU MDR and IVDR do not apply in Great Britain but do apply in Northern Ireland.
• The UKCA mark is not recognised in the EU, EEA or Northern Ireland.
• Government plans primary legislation for a future licensing approach for some devices, e.g. software and AI; no timetable given.

Purpose

Domestic GB route to show devices meet UK MDR 2002 essential requirements.

Who it applies to

Manufacturers choosing to place devices on the GB market with UKCA marking.

Applicable products

All device types for GB; not valid for Northern Ireland or EU markets.

Classification

Class I (self-certified unless sterile or measuring), Is/Im, IIa, IIb, III, AIMD; IVD categories.

General requirements

• Classify under UK MDR 2002 rules.
• Self-certify Class I non-sterile, non-measuring devices and general IVDs.
• Use a UK Approved Body (listed on the UKMCAB database) for sterile/measuring Class I and higher classes.
• Draw up a UK declaration of conformity and affix the UKCA mark.

Typical documentation

• Technical documentation
• UK declaration of conformity
• Approved body certificate where applicable

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Classify, complete the relevant conformity assessment, sign the declaration, mark and register with MHRA.

Important notes

• Under current GB rules (based on the former EU Directives) there is no separate 'Class Ir'; reusable non-sterile, non-measuring Class I surgical instruments can self-certify for UKCA, unlike EU MDR where reuse aspects need a notified body.
• A pre-market statutory instrument to update UKCA requirements is planned; earlier UK consultation proposals included Approved Body review of reusability aspects of reusable surgical instruments.

Purpose

Gives MHRA visibility of devices and responsible parties on the GB market.

Who it applies to

UK-based manufacturers, or the UK Responsible Person acting for a non-UK manufacturer.

Applicable products

All device classes, whether UKCA or CE marked. Devices already registered for Northern Ireland can be placed on the GB market without re-registration.

Classification

All classes.

General requirements

• Register through the MHRA device registration system before placing the device on the GB market.
• Only UK-based manufacturers can register directly; others act through a UKRP.
• Pay the registration fee (MHRA guidance: £240 per application since 8 February 2024).

Typical documentation

• Device and manufacturer details
• Evidence of UKRP appointment (for non-UK manufacturers)
• Conformity evidence for higher-risk devices

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Create an account, submit device registrations and keep them updated.

Important notes

• Registration is not MHRA approval of the device.

Purpose

Provides a UK-based party accountable to MHRA for overseas manufacturers' devices on the GB market.

Who it applies to

Non-UK manufacturers placing devices on the GB market (UKCA or CE marked).

Applicable products

All device types placed on the GB market by non-UK manufacturers.

General requirements

• Written evidence of the UKRP's authority from the manufacturer.
• UKRP registers devices, ensures DoC and technical documentation exist, keeps them available to MHRA and responds to MHRA requests.
• UKRP passes complaints and incident reports to the manufacturer and ends the mandate (informing MHRA) if the manufacturer breaches obligations.

Typical documentation

• Written UKRP mandate
• Copies of DoC and technical documentation access

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Appoint the UKRP before GB registration; the UKRP's details appear on labelling where required.

Important notes

• Importers and distributors do not need a UKRP but may act as one.
• Former 'authorised representative' MHRA accounts not converted to UKRP were suspended from 1 January 2022; MHRA stated unconverted accounts would be closed by 30 March 2026.

Purpose

Keeps EU-certified devices available in GB without separate UKCA certification.

Who it applies to

Manufacturers placing CE-marked devices on the GB market (registration with MHRA and UKRP still apply).

Applicable products

Devices compliant with EU MDR/IVDR or still-valid Directive certificates/declarations.

General requirements

• Valid CE marking and certificates (until the stated date or earlier certificate expiry).
• Current MHRA guidance: MDD/AIMDD devices until 30 June 2028; IVDD devices until 30 June 2030; EU MDR and IVDR devices until 30 June 2030.
• Register with MHRA and appoint a UKRP if based outside the UK.

Typical documentation

• EU DoC
• Notified body certificates where applicable

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

No UK conformity assessment needed while acceptance applies; register the device with MHRA.

Important notes

• Government response (21 Oct 2026): legislate to recognise MDR/IVDR CE-marked devices indefinitely and align GB MDD transitional arrangements with EU timelines.
• Northern Ireland requires CE marking under EU rules (plus UKNI where a UK body did the assessment).

Purpose

Implements EU device rules in Northern Ireland under the Windsor Framework arrangements.

Who it applies to

Manufacturers and economic operators placing devices on the Northern Ireland market.

Applicable products

All devices for the NI market. UKCA marking alone is not accepted.

Classification

EU MDR / IVDR classes.

General requirements

• CE marking under EU rules; UKNI indication also needed where a UK notified body did the mandatory third-party assessment.
• GB-based manufacturers appoint an EU or NI-based authorised representative.
• Register devices with MHRA as required (e.g. custom-made devices within 28 days of being made available).

Typical documentation

• EU DoC and technical documentation
• Authorised representative mandate

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Follow EU MDR/IVDR processes; register with MHRA where required.

Important notes

• Devices registered for NI can be placed on the GB market without re-registration.

Purpose

Improves incident traceability and trend detection and allows MHRA to act faster on safety issues.

Who it applies to

Manufacturers (and UKRPs) of devices placed on the GB market, UKCA or CE marked.

Applicable products

All devices on the GB market.

Classification

Applies to all classes, with reporting depth scaled to class.

General requirements

• Maintain a PMS system and plan proportionate to risk.
• Submit vigilance reports for UK incidents and take required field safety corrective action.
• Produce periodic PMS/safety reports as required by class.

Typical documentation

• PMS plan
• PMS report / periodic safety update report
• Incident and FSCA records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Collect and analyse post-market data and report to MHRA within the regulation's timelines.

Important notes

• Applies to CE-marked devices on the GB market as well as UKCA-marked ones.

Purpose

Sets safety and effectiveness requirements, licensing, labelling and post-market obligations for medical devices sold in Canada.

Who it applies to

Manufacturers (domestic and foreign), importers and distributors selling medical devices in Canada.

Applicable products

Medical devices and IVDs; custom-made, special access and investigational devices have separate provisions.

Classification

Class I (lowest) to Class IV (highest) under Schedule 1 rules. Rule 3 places surgical or dental instruments (reusable, not connected to an active device) in Class I despite Rules 1 and 2.

General requirements

• Classify the device using Schedule 1.
• Class II, III, IV: obtain a Medical Device Licence before sale.
• Class I manufacturers, and importers/distributors of all classes: hold an MDEL unless exempt.
• Meet labelling requirements, distribution records, complaint handling, mandatory problem reporting and recall obligations.

Typical documentation

• Classification rationale
• MDL application and MDSAP certificate (Class II-IV)
• MDEL application and procedures
• Labelling

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Classify, obtain MDL and/or MDEL as applicable, then maintain post-market obligations.

Important notes

• Reusable surgical instruments are typically Class I in Canada (Rule 3), so they need no MDL; disposable instruments or those connected to an active device may be Class II.
• Manufacturers are responsible for classifying their own devices.

Purpose

Pre-market review that the device meets safety and effectiveness requirements, scaled to risk class.

Who it applies to

The manufacturer (domestic or foreign) named on the label of a Class II-IV device.

Applicable products

Class II-IV devices. Class I devices do not need an MDL (but are covered by MDEL rules).

Classification

Class II: attestation-based application; Class III and IV: more detailed premarket review evidence (section 32).

General requirements

• Submit a new licence application with content required for the class (section 32 of the Regulations).
• Include a valid MDSAP certificate issued by a recognised auditing organization with new applications.
• Pay the applicable fee.
• Apply for licence amendments for significant changes.

Typical documentation

• Licence application form
• MDSAP certificate
• Class III/IV: safety and effectiveness evidence, labelling, summaries per section 32

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit the application to Health Canada; once issued, the device may be sold by MDEL-holding importers/distributors.

Important notes

• An MDL is specific to the device(s) and manufacturer named; it is not a company-wide approval.

Purpose

Licenses establishments to import or sell devices and confirms they have procedures for records, complaints, problem reporting and recalls.

Who it applies to

Importers and distributors (domestic or foreign) of any class, and Class I manufacturers selling in Canada.

Applicable products

All device classes. Not needed for Class II-IV manufacturers selling their own licensed devices.

Classification

Applies across Class I-IV, by activity rather than device class.

General requirements

• Apply for an MDEL and pay the fee before importing or selling.
• Have documented procedures where applicable (distribution records, complaint handling, mandatory problem reporting, recalls).
• Notify Health Canada within 15 calendar days of changes to licence information.
• Submit the annual licence review before 1 April each year.

Typical documentation

• MDEL application (FRM-0292)
• Attested procedures
• List of manufacturers and device classes handled

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply to Health Canada's establishment licensing unit; maintain the licence through annual review and inspections.

Validity and renewal

Ongoing subject to annual licence review submitted before 1 April each year.

Important notes

• Exempt: retailers, health care facilities, Class II-IV manufacturers selling their own licensed devices, Class I manufacturers selling only through an MDEL holder, and others listed in GUI-0016.
• Volume of sales does not matter; leasing/renting counts as selling.
• An MDEL does not authorise or certify the safety of any device.

Purpose

Single audit programme (ISO 13485 plus participating regulators' requirements) used to show the manufacturer's QMS meets Canadian requirements.

Who it applies to

Manufacturers applying for or holding Class II-IV medical device licences.

Applicable products

Class II-IV devices. Not required for Class I devices.

Classification

Class II-IV.

General requirements

• Be audited under MDSAP by a recognised auditing organization.
• Provide the certificate number, auditing organization name and a legible certificate copy with each new licence application.
• Maintain certification through surveillance and recertification audits.

Typical documentation

• MDSAP certificate

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Engage an MDSAP auditing organization, complete audits, then submit the certificate with the licence application.

Important notes

• CMDCAS certificates have not been accepted since 1 January 2019.
• MDSAP audits can also serve the US, Brazil, Japan and Australia regulators, but each regulator decides how it uses the reports.

Purpose

Ensures medical devices supplied in Australia meet safety and performance standards through ARTG inclusion and ongoing sponsor obligations.

Who it applies to

Australian sponsors (importers, local manufacturers, exporters) and the overseas manufacturers whose evidence they rely on.

Applicable products

Medical devices and IVDs; exemptions exist for e.g. clinical trial supply, Special Access Scheme, Authorised Prescribers and custom-made devices meeting conditions.

Classification

Non-IVD: Class I (incl. sterile and measuring), IIa, IIb, III, AIMD. IVD: Class 1-4. TGA classification guidance lists reusable surgical instruments as Class I.

General requirements

• Classify the device and confirm it meets the Essential Principles.
• Hold manufacturer conformity assessment evidence (TGA certificate or acceptable comparable overseas regulator evidence; manufacturer declaration for Class I non-sterile, non-measuring).
• Australian sponsor applies for ARTG inclusion.
• Sponsor meets ongoing obligations (adverse event reporting, records, recalls, advertising rules).

Typical documentation

• Manufacturer evidence (certificates or declaration of conformity)
• Essential Principles checklist and supporting data
• Labelling and IFU
• Sponsor-manufacturer agreement

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Manufacturer prepares evidence; sponsor lodges it (where needed) and the ARTG application; TGA includes the device, possibly after application audit.

Important notes

• Overseas manufacturers cannot apply directly; they need an Australian sponsor.
• Class I non-sterile reusable instruments are included on a manufacturer's declaration; sterile-supplied Class I devices follow the route for devices other than Class I.

Purpose

Legal authorisation to supply a device in Australia.

Who it applies to

Australian sponsors of medical devices.

Applicable products

All classes unless an exemption or exclusion applies.

Classification

Evidence required depends on class; higher classes may be selected for application audit.

General requirements

• Submit manufacturer evidence accepted by TGA (not required as a separate step for Class I non-sterile, non-measuring devices, which rely on a declaration of conformity uploaded with the application).
• Lodge the ARTG application with device details and pay fees.
• Certify that the device complies with the Essential Principles and that conformity assessment procedures have been applied.

Typical documentation

• Manufacturer evidence
• Declaration of conformity
• Device information (GMDN, classification, intended purpose)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applied for through TGA Business Services; inclusion may follow an application audit for some device types.

Important notes

• ARTG inclusion is for a 'kind of device' under a sponsor; changing sponsor requires a TGA process.

Purpose

Places legal responsibility for devices supplied in Australia on a locally accountable party.

Who it applies to

Australian-based persons or companies that import, manufacture or export medical devices.

Applicable products

All ARTG-included devices.

General requirements

• Be an Australian-based legal entity.
• Hold, or have a written agreement to obtain from the manufacturer, information substantiating Essential Principles compliance and conformity assessment.
• Report adverse events and take part in recalls.
• Keep records and comply with advertising rules.

Typical documentation

• Manufacturer agreement
• Distribution records
• Adverse event and recall records

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Obligations last as long as the ARTG inclusion has effect.

Important notes

• Foreign exporters usually supply through an Australian distributor or a specialist sponsor service.

Purpose

Lets TGA rely on assessments by trusted overseas regulators to reduce duplication, while keeping TGA certification for cases where needed.

Who it applies to

Manufacturers (and their sponsors) of devices other than Class I non-sterile, non-measuring.

Applicable products

Class Is/Im, IIa, IIb, III, AIMD and IVD Class 2-4. Some device types (e.g. certain Class 4 IVDs and Australian manufacturers of some IVDs) require TGA assessment.

Classification

Evidence acceptable varies by class (see TGA guidance tables).

General requirements

• Choose TGA conformity assessment certification or comparable overseas regulator (COR) evidence.
• COR evidence named by TGA includes EU notified body certificates, FDA 510(k)/PMA decisions, Health Canada licences, Japan MHLW/PMDA approvals, Singapore HSA registration, UK approved body certificates and MDSAP certificates/reports.
• Evidence must cover the same device and intended purpose as the Australian supply.
• Submit manufacturer evidence for TGA acceptance before the ARTG application where required.

Typical documentation

• Certificates/approvals with scope matching the device
• Audit reports where requested
• Declaration of conformity

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Sponsor lodges manufacturer evidence in TGA Business Services; once accepted, it is linked to ARTG applications.

Important notes

• Using COR evidence does not remove the need to meet Australian Essential Principles, labelling and sponsor requirements.

Purpose

Regulates manufacture, marketing and post-market safety of medical devices in Japan.

Who it applies to

Marketing Authorization Holders in Japan, domestic manufacturers and registered foreign manufacturers.

Applicable products

Medical devices and IVDs, including software as a medical device.

Classification

Class I (general, extremely low risk), Class II (controlled, low risk), Class III and IV (highly controlled, medium/high risk).

General requirements

• Market through a licensed MAH located in Japan.
• Register each manufacturing site, including foreign manufacturers (foreign manufacturer registration with MHLW via PMDA).
• Use the pathway for the class: notification (todokede), certification (ninsho) or approval (shonin).
• Comply with the QMS Ministerial Ordinance and post-market safety rules.

Typical documentation

• Notification, certification or approval application
• Manufacturing site registration
• QMS documentation
• Japanese labelling/package insert

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Appoint/obtain MAH, register manufacturing sites, file under the correct pathway, pass QMS conformity checks where required, then market.

Important notes

• Foreign manufacturers can submit applications directly to PMDA or an RCB but must designate a Japan-based MAH in all cases.

Purpose

Records low-risk devices placed on the Japanese market.

Who it applies to

MAHs marketing Class I general medical devices.

Applicable products

Class I general medical devices.

Classification

Class I.

General requirements

• Confirm Class I status under the Japanese generic name (JMDN) classification.
• MAH submits the notification to PMDA before marketing.
• Manufacturing sites registered as required.

Typical documentation

• Marketing notification form
• Device information under the relevant generic name

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Filed by the MAH; no pre-market review.

Important notes

• Classification follows Japanese generic name lists; do not assume a device is Class I based on EU or US class.

Purpose

Delegates review of standardised lower-risk devices to registered third parties.

Who it applies to

MAHs of devices covered by certification standards (ninsho kijun).

Applicable products

Class II (and designated Class III) devices for which certification standards exist; others need approval.

Classification

Class II and designated Class III.

General requirements

• Confirm the device falls under a certification standard.
• Apply to a Registered Certification Body with conformity evidence.
• QMS conformity assessment by the RCB.

Typical documentation

• Certification application
• Conformity to certification standard and essential principles
• QMS evidence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

RCB reviews and issues certification; no PMDA review or MHLW approval needed.

Important notes

• RCBs are registered by MHLW; they are not ISO certification bodies in this role.

Purpose

Full pre-market review of higher-risk or non-standardised devices.

Who it applies to

MAHs (or foreign manufacturers through a designated MAH) of devices requiring approval.

Applicable products

Class IV; Class II and III devices without certification standards.

Classification

Class II-IV where certification standards do not apply; always for Class IV.

General requirements

• Submit approval application with technical and, where needed, clinical evidence to PMDA.
• Pass QMS conformity inspection.
• Obtain MHLW approval before marketing.

Typical documentation

• Approval application dossier (STED-style summary)
• Clinical data where required
• QMS evidence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

PMDA consultations, review, QMS inspection, then MHLW approval.

Important notes

• Foreign manufacturers may hold approval themselves and designate a Japan-based MAH (Designated MAH) to market the device.

Purpose

Ensures a domestic party is legally accountable for devices on the Japanese market.

Who it applies to

Japanese companies marketing devices and foreign manufacturers exporting to Japan.

Applicable products

All device classes.

Classification

MAH licence category depends on the device classes marketed.

General requirements

• MAH holds a marketing licence issued by the prefecture.
• MAH maintains quality assurance (GQP-type) and post-market safety (GVP-type) systems as required by ordinance.
• Foreign manufacturers register their manufacturing sites with MHLW through PMDA and obtain a manufacturer code.
• A foreign manufacturer holding approval/certification in its own name designates a Japanese MAH (Designated MAH).

Typical documentation

• MAH licence
• Designation agreement
• Foreign manufacturer registration

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Select an MAH or Designated MAH service, register foreign sites, then file product applications.

Important notes

• Choosing a distributor as MAH ties the product registration to that company; a Designated MAH arrangement keeps approval with the foreign manufacturer.

Purpose

Sets quality management requirements for medical device manufacture and marketing in Japan.

Who it applies to

MAHs and registered manufacturing sites (domestic and foreign).

Applicable products

Devices requiring certification or approval are subject to QMS conformity assessment; Class I scope differs.

Classification

Inspection applies mainly to Class II-IV.

General requirements

• Implement a QMS meeting the Ordinance (aligned with ISO 13485; revised by Ordinance No. 60 of 2021).
• Undergo QMS conformity assessment by PMDA or an RCB at application and periodically.
• MDSAP audit reports can be used by PMDA in QMS inspections.

Typical documentation

• QMS documentation and records
• Audit/inspection reports (MDSAP reports where used)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

QMS audits linked to certification/approval applications and periodic renewals.

Important notes

• ISO 13485 certification alone does not substitute for Japanese QMS conformity assessment.

Purpose

Sets the national rules for classification, product filing/registration, manufacturing, distribution, import, labelling, UDI and post-market obligations. Detailed rules include the SAMR Measures for Registration and Filing of Medical Devices (Order No. 47, in force 1 October 2021).

Who it applies to

Domestic and overseas registrants/filers, manufacturers, distributors and users of medical devices in mainland China.

Applicable products

Medical devices (IVDs have parallel SAMR Order No. 48 rules).

Classification

Class I (low risk, routine control), Class II (moderate risk, strict control), Class III (higher risk, special measures); class is set mainly through NMPA's Medical Device Classification Catalogue.

General requirements

• Class I: product filing; Class II and III: product registration (Art. 13)
• Overseas registrants/filers must designate an enterprise legal person in China as agent
• Manufacturing: Class I production filing; Class II/III production licence (Arts. 31–32)
• Distribution: Class II business filing; Class III business licence (Arts. 41–42)
• Chinese-language labels and IFU for imported devices (Art. 57)
• Adverse event monitoring, recall and traceability systems (Arts. 20, 62)

Typical documentation

• Risk analysis, product technical requirements, inspection (test) reports, clinical evaluation, IFU and labels, QMS documents (Art. 14)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Determine class from the catalogue, prepare technical requirements and test reports, conduct clinical evaluation unless exempt, then file (Class I) or apply for registration (Class II/III) with the competent authority.

Validity and renewal

Registration certificates, production licences and business licences are valid for five years (Arts. 22, 32, 42).

Important notes

• Registrant/filer (the legal manufacturer) is responsible for the device across its lifecycle, even if production is entrusted.
• NMPA has indicated further revision of the Regulations; check for amendments.

Purpose

Records low-risk devices with the regulator before marketing; filing is complete once compliant documents are submitted.

Who it applies to

Domestic filers (municipal authority where located) and overseas filers acting through their designated Chinese enterprise legal person (NMPA).

Applicable products

Products listed in NMPA's Class I Medical Device Product Catalogue (Announcement 2021 No. 158, effective 1 January 2022) and Class I entries of the Classification Catalogue.

Classification

Class I only.

General requirements

• Product risk analysis and product technical requirements
• Inspection report – may be the filer's own self-test report
• Clinical evaluation materials (many Class I products are exempt)
• IFU and label drafts; QMS documents
• Imported products: proof the device may be marketed in the country/region of origin

Typical documentation

• Filing form and materials listed in Art. 14 of Order 739 and SAMR Order No. 47

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit the filing materials; once complete and compliant the authority records the filing and publishes the filing information.

Important notes

• NMPA's Passive Surgical Instruments sub-catalogue (02) includes many forceps, scissors and similar hand instruments as Class I, but class depends on the specific catalogue entry (e.g. sterile, special anatomical or energy-related uses can be higher) – check the exact item.
• The 2021 Class I catalogue removed several products formerly filed as Class I (e.g. medical cold compress products) and banned certain added ingredients.

Purpose

Pre-market review of safety and effectiveness for moderate- and higher-risk devices.

Who it applies to

Domestic registrants (provincial authority for Class II, NMPA for Class III) and overseas registrants via their Chinese agent (NMPA).

Applicable products

Class II and III medical devices; innovative devices not yet marketed abroad may be exempt from the origin-country approval proof.

Classification

Class II and III.

General requirements

• Product technical requirements (产品技术要求)
• Inspection (type test) report – self-test or by a qualified testing institution
• Clinical evaluation, via clinical trial or analysis of literature/data on same-type devices; exemption where the device is listed or otherwise shown safe and effective by non-clinical evaluation (Art. 24)
• Clinical trials filed with the provincial authority; higher-risk Class III trials need NMPA approval (Arts. 26–27)
• QMS documents relating to R&D and production; registration quality system inspection may apply
• Imported devices: proof of marketing approval in country/region of origin

Typical documentation

• Risk analysis; technical requirements; test reports; clinical evaluation; IFU and labels; QMS documents; origin-country approval (imports)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit the registration application; technical review by the evaluation centre; decision and issue of registration certificate. Renewal must be applied for at least six months before expiry.

Validity and renewal

Five years (Art. 22).

Important notes

• Registration is product-level; the domestic manufacturer also needs a production licence for Class II/III.
• Fees and review timelines are set by separate rules and are not reproduced here.

Purpose

Gives NMPA a responsible legal entity in China for imported devices.

Who it applies to

Overseas registrants (Class II/III) and filers (Class I).

Applicable products

All imported medical devices.

General requirements

• Designate an enterprise legal person in China to submit filing/registration (Arts. 15–16)
• Agent assists with QMS, post-market research and risk control, adverse event monitoring, re-evaluation, traceability and recall duties (Art. 20)
• Chinese IFU must name the country of origin and the designated Chinese enterprise (Art. 57)

Typical documentation

• Agent appointment documents per SAMR Order No. 47

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Appoint the agent before submitting the Class I filing or Class II/III registration to NMPA.

Important notes

• The agent is distinct from importers/distributors, who need their own business filing or licence depending on class.

Purpose

Establishment-level controls for those who manufacture or trade devices in China.

Who it applies to

Manufacturers located in China and businesses distributing devices in China (including importers' distribution operations).

Applicable products

All classes; some Class II products whose safety is unaffected by distribution may be exempt from business filing (Art. 41).

Classification

Production: Class I filing (municipal); Class II/III licence (provincial). Distribution: Class II filing, Class III licence (municipal).

General requirements

• Production quality management practice (device GMP) covering design, equipment, materials, process control, release and staffing (Art. 33)
• Distributors operate a QMS meeting NMPA's distribution quality practice (Art. 44)
• Entrusted production allowed with written agreement; high-risk implantables may not be entrusted (Art. 34)

Typical documentation

• Licence/filing applications with compliance materials and the product registration certificate (production licence)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Authorities decide on production and Class III business licences within 20 working days of acceptance.

Validity and renewal

Production and business licences valid for five years (Arts. 32, 42).

Important notes

• These rules apply to activities inside China; overseas factories are covered through registration and possible overseas inspection rather than a Chinese production licence.

Purpose

Ensures accurate information, traceability and safety monitoring after market entry.

Who it applies to

Registrants/filers (and their China agents), manufacturers, distributors and users.

Applicable products

All devices; UDI applies in stages by device category as set by NMPA.

Classification

UDI phased by category (higher-risk first) under NMPA rules.

General requirements

• IFU and labels must match registered/filed content and contain required items (Art. 39)
• Imported devices must carry Chinese IFU and labels; used, expired or obsolete devices may not be imported (Art. 57)
• UDI system implemented step by step by category (Art. 38)
• Registrants set up adverse event monitoring and report to the technical monitoring institution (Art. 62)
• Recall, traceability and re-evaluation systems (Art. 20)
• Imported devices are subject to entry inspection; failing devices may not be imported (Art. 58)

Typical documentation

• Approved labels/IFU; UDI database records; adverse event reports

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Labels are approved as part of filing/registration; UDI data are uploaded to NMPA's UDI database per the applicable phase; adverse events are reported to the national monitoring system.

Important notes

• Detailed labelling rules (Provisions for Medical Device IFU and Labels) and adverse event monitoring measures are separate NMPA rules not reviewed here.

Purpose

MDR 2017 (in force 1 January 2018) sets risk classification, licensing for manufacture, import, clinical investigation and sale, QMS (Fifth Schedule) and post-market duties.

Who it applies to

Indian manufacturers, importers (via an Indian authorised agent), distributors/sellers and clinical investigators of medical devices and IVDs.

Applicable products

Medical devices and IVDs; licensing was extended in phases to all devices, with Class A non-sterile, non-measuring devices moved to a registration-only route (G.S.R. 777(E), 2022).

Classification

Class A (low), B (low–moderate), C (moderate–high), D (high), using First Schedule rules; CDSCO publishes product-wise risk classification lists.

General requirements

• Manufacturing licence: Class A/B from State Licensing Authority (MD-3 application / MD-5 licence); Class C/D from Central Licensing Authority (MD-7 / MD-9)
• Import licence for all classes from the Central Licensing Authority (MD-14 application / MD-15 licence)
• Class A non-sterile, non-measuring devices: registration number via CDSCO online system instead of licence
• QMS per Fifth Schedule for manufacturers
• Labelling per MDR 2017 and post-market (vigilance) obligations

Typical documentation

• Device master file and plant master file (manufacture); Fifth Schedule QMS evidence; free sale and QMS certificates for imports

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applications are filed on CDSCO's online medical devices portal; licences are granted after document review and, where applicable, audit/inspection.

Important notes

• Manufacturers and importers cannot simply choose their class; CDSCO's classification lists and the licensing authority's decision govern.
• Wholesale/retail sale of devices is controlled through registration certificates for sale (Form MD-42 is cited in CDSCO import checklists as one accepted credential of an authorised agent).

Purpose

Licenses the manufacturing site and the devices it makes for sale in India.

Who it applies to

Manufacturers in India (loan-licence variants exist for using another licensee's facility).

Applicable products

Devices of the relevant class made in India; Class A non-sterile, non-measuring devices follow the registration route instead (see separate entry).

Classification

Class A/B: SLA; Class C/D: CLA.

General requirements

• Quality management system conforming to the Fifth Schedule of MDR 2017
• Device master file and plant master file
• Competent technical staff
• Audit of the site (by notified body or authority, depending on class) before or after grant as the rules specify

Typical documentation

• Application on MD-3 (Class A/B) or MD-7 (Class C/D) with fee
• Device master file, plant master file, test reports, labels/IFU, essential principles evidence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply on the CDSCO online portal; the licensing authority reviews and arranges audit/inspection, then grants MD-5 or MD-9.

Important notes

• Third-party legal sources state that MDR 2017 licences remain valid indefinitely if retention fees are paid; not confirmed on CDSCO site during this research.

Purpose

Central authorization for importing specified devices from specified foreign manufacturers.

Who it applies to

Indian authorised agents of foreign manufacturers holding a manufacturing licence, wholesale licence or MD-42 sale registration, with power of attorney from the manufacturer.

Applicable products

Imported medical devices of Classes A–D (Class A non-sterile, non-measuring devices may instead use registration – see separate entry).

Classification

All classes; evidence expectations rise with class.

General requirements

• Authorised agent in India with a valid sale/wholesale credential
• Power of attorney from the foreign manufacturer
• Evidence of marketing approval/free sale in the origin country or other recognised markets
• QMS certificate (e.g. ISO 13485) for the manufacturing site
• Device master file and plant master file

Typical documentation

• MD-14 application with fee and CDSCO checklist documents
• Power of attorney; free sale certificate; QMS certificate; DMF/PMF; labels and IFU

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit MD-14 on the CDSCO portal; CLA reviews and grants MD-15 for the listed devices and manufacturer site.

Important notes

• Retention of the MD-15 licence requires periodic retention fees according to CDSCO checklists (not verified directly).

Purpose

A lighter route for the lowest-risk devices while keeping them identifiable to the regulator.

Who it applies to

Manufacturers and importers of devices on CDSCO's list of Class A non-sterile, non-measuring devices.

Applicable products

Only listed Class A devices that are neither sterile nor have a measuring function; any sterile or measuring variant is not covered.

Classification

Class A (non-sterile, non-measuring) only.

General requirements

• Obtain a registration number from the CDSCO Online System for Medical Devices
• Check the device is on CDSCO's current NSNM list (the list is revised from time to time)

Typical documentation

• Online registration information as required by Chapter IIIB of MDR 2017

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Register on the CDSCO portal to receive the registration number before placing the device on the market.

Important notes

• CDSCO addenda also exempt these devices from Chapter XI (sale) requirements; the full list of exempted chapters should be checked in the gazette text.
• Relevant to non-sterile reusable hand instruments only if they appear on CDSCO's list – supplying them sterile removes eligibility.

Purpose

Sets the minimum QMS requirements checked during licensing audits and inspections.

Who it applies to

Manufacturers holding or applying for MD-5/MD-9 licences (and their loan-licence equivalents).

Applicable products

All licensed device manufacturing in India.

General requirements

• Documented QMS covering management responsibility, resources, product realisation, measurement and improvement
• Records available for audit by notified bodies or licensing authorities

Typical documentation

• Quality manual, procedures and records; plant master file

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Assessed in pre-licence and periodic audits.

Important notes

• ISO 13485 certification is commonly used as evidence but the legal requirement is the Fifth Schedule.

Purpose

The Medical Devices Rules, 2017 (notified 16 January 2018 under the DRAP Act, 2012) set up a two-layer system: licensing of the establishment that manufactures or imports, and enlistment or registration of each device. The Medical Device Board (MDB) of DRAP is the decision-making body.

Who it applies to

Local manufacturers and importers placing medical devices, components or accessories on the Pakistani market, and establishments exporting devices (export permits).

Applicable products

Instruments, apparatus, implants, in-vitro reagents, software and similar articles with a medical purpose, excluding products whose primary action is pharmacological, immunological or metabolic.

Classification

Four risk classes: A (low), B (low–moderate), C (moderate–high), D (high), assigned using the rules in Schedule A of MDR 2017 (GHTF/IMDRF-based).

General requirements

• Establishment licence to manufacture or to import (separate licence per premises)
• Enlistment of Class A devices; registration of Class B, C and D devices
• Applications for enlistment/registration can only be made by a licensed local manufacturer or a licensed importer acting as authorized representative
• Labelling, warranty (Form-5) and record-keeping conditions attached to enlistment/registration
• Adverse event and safety-action reporting to the MDB
• Export permit for exporting medical devices

Typical documentation

• Application forms and checklists published by DRAP for each licence/enlistment/registration type
• Proof of fee deposit as per Schedule C
• Manufacturer credentials, QMS certificates and technical information (see separate entries)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Obtain the establishment licence first (Form-1 manufacture / Form-2 import), then apply for enlistment (Form-6/6A) or registration (Form-7/7A) of each device through DRAP's online system with hard-copy submission where required.

Validity and renewal

Establishment licences and enlistment/registration certificates are valid for five years unless suspended or cancelled (MDR 2017, rules 5 and 15).

Important notes

• Establishment licensing (who you are/where you operate) and product enlistment/registration (what you sell) are separate approvals; both are needed to import or manufacture for sale.
• The Rules have been amended several times (e.g. S.R.O. 526(I)/2021, 1500(I)/2021, 430(I)/2022, 559(I)/2022, 224(I)/2023, 1049(I)/2025); always check DRAP's consolidated version.
• DRAP's GDP guidance for medical devices and the storage-inspection checklist apply to importers' premises.

Purpose

Confirms that the premises, equipment, staff and storage of a manufacturer or importer are suitable before it handles medical devices.

Who it applies to

Local manufacturers of medical devices, components or accessories, and importers (who also act as the authorized representative of foreign manufacturers).

Applicable products

All classes of medical devices, components and accessories. A separate licence is issued for each manufacturing or import premises; declared distribution godowns in federal/provincial capitals can be covered under the licence.

Classification

Not class-dependent; two licence types: manufacture and import.

General requirements

• Suitable premises, space, plant and equipment for the intended activity (rule 6 conditions)
• Named qualified technical person(s) to supervise manufacture or import/storage
• Storage meeting DRAP good storage / good distribution practice expectations for medical devices
• Possible inspection of premises by an MDB panel of experts before grant
• Compliance with licence conditions throughout validity

Typical documentation

• Application on Form-1 (manufacture) or Form-2 (import), via DRAP's online licensing system plus hard copy
• Fee as per rule 63 / Schedule C
• Details of premises, qualified technical persons and partners/directors, with affidavits as required by the form
• DRAP checklist for grant or renewal of the relevant licence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply online and submit the hard-copy form; DRAP may inspect the premises (importers against the Good Storage Practices checklist); the MDB then grants the licence (Form-3 manufacture / Form-4 import).

Validity and renewal

Five years from issue unless suspended or cancelled (rule 5(3)); renewal under the rules.

Important notes

• The licence does not authorize sale of any specific device – each device still needs enlistment or registration.
• Foreign manufacturers cannot apply directly; their Pakistani importer holds the licence and applies for product enlistment/registration.

Purpose

Product-level authorization confirming that a specific device meets DRAP's safety, performance and quality requirements before sale.

Who it applies to

Licensed local manufacturers (Form-6 / Form-7) and licensed importers acting as authorized representative of the foreign manufacturer (Form-6A / Form-7A).

Applicable products

All medical devices. Class A = enlistment; Classes B, C and D = registration. Devices may be grouped per Schedule B rules.

Classification

Enlistment for Class A; registration for Class B, C and D (rule 13).

General requirements

• Valid establishment licence of the applicant
• Application on the correct form with fee and documents/samples
• Manufacturing methods and testing procedures must follow principles of validation
• Labelling and prescribing information as approved in the country of origin or in the EU, USA, Japan, Canada or Australia
• After approval: approved licence/registration number and MRP shown on labelling; changes need MDB approval

Typical documentation

• Form-6/6A or Form-7/7A and the DRAP checklist
• Notarized letter of authorization/agency agreement from the manufacturer (imports)
• Free sale certificate from country of origin and/or reference country, attested as required
• ISO 13485 / GMP certificate (and full QA or design-examination certificate where applicable), notarized
• Declaration of conformity and essential principles checklist
• Labels, IFU and further technical data for devices not approved in reference countries

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit the application to the MDB; DRAP may inspect the establishment (inspection may be waived where reliance applies); if satisfied, the MDB enters the device in the register and issues a certificate (Form-8/8A) with an enlistment/registration number.

Validity and renewal

Five years from enlistment/registration (rule 15(4)); renewal is applied for under rule 16, with a late-renewal window of up to one year with additional fee.

Important notes

• Rule 15(2) allows registration to rely on approvals from listed reference regulators (USA, Japan, Australia, Canada, several European countries, UK), WHO prequalification or CE marking by a NANDO-listed notified body.
• S.R.O. 224(I)/2023 gave licensed importers/manufacturers temporary exemption from enlistment/registration (Classes C and D until 31 Dec 2023; Classes A and B until 31 Dec 2024). These dates have passed – assume enlistment/registration is now required unless DRAP has issued a further extension.
• Certificates cannot be transferred to another person without MDB approval.

Purpose

Sets the risk class that decides whether a device is enlisted or registered and how much evidence is needed.

Who it applies to

Manufacturers and importers, who must state the class and the classification rule applied in their application.

Applicable products

All medical devices including IVDs (IVD classification and device grouping are in the Schedules).

Classification

Class A low hazard (e.g. tongue depressors), Class B low–moderate (e.g. hypodermic needles, suction equipment), Class C moderate–high (e.g. lung ventilators, bone fixation plates), Class D high (e.g. heart valves, implantable defibrillators).

General requirements

• Apply Schedule A classification rules (GHTF/IMDRF-based) considering intended use, duration of contact, invasiveness and whether the device is active
• Use Schedule B rules when grouping devices in one application
• Declare the class with the relevant rule in the enlistment/registration application

Typical documentation

• Classification justification citing the Schedule A rule

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

The manufacturer/importer determines the class; disputes can be referred to the MDB for decision.

Important notes

• MDR 2017 defines a 'reusable surgical instrument' as one used for cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping etc., not connected to an active device, and intended to be reused after cleaning, disinfection or sterilization.
• Schedule A Rule 6: surgically invasive devices for transient use are Class B unless they are reusable surgical instruments (Class A); a surgical instrument connected to an active device is above Class A. Rule 6 has further exceptions (e.g. energy-supplying devices) that move devices higher.
• Single-use surgical instruments (e.g. single-use scalpels) are given as Class B examples under Rule 6.

Purpose

Explains what evidence DRAP generally expects in an enlistment/registration dossier.

Who it applies to

Importers (Form-6A/7A) and local manufacturers (Form-6/7) preparing applications.

Applicable products

Content varies by class and form; the deepest technical section applies to devices not approved or on free sale in the reference countries listed in the Rules.

Classification

Applies to all classes; checklist content differs between Class A enlistment and Class B–D registration.

General requirements

• Manufacturer details including all sites and sub-assembly processes
• Product details: brand/generic name, HS/GMDN code, class and rule, manufacturing/QC summary, shelf life and storage with stability justification, proposed MRP
• Statement whether the device is for export or local market
• Grouping information, list of configurations, accessories and intended use

Typical documentation

• Notarized agency agreement/letter of authorization naming the importer
• Free sale certificate from the country of origin attested by the Embassy of Pakistan, and/or free sale certificate from a reference regulator
• ISO 13485 / GMP certificate; full QA or design-examination certificate where applicable (notarized)
• Essential principles of safety and performance; declaration of conformity on manufacturer letterhead
• Label, packaging and IFU as approved in the country of origin
• For devices not approved in reference countries: contraindications/warnings, sterilization/measuring validation, software validation (active devices), biological-material and biocompatibility data, pre-clinical test reports
• Declaration on stamp paper and a soft copy of the application

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Compile the dossier against the DRAP checklist for the relevant form and submit with the application.

Important notes

• This list is from the official DRAP checklist for imported Class B–D devices; Class A and local-manufacture checklists are separate and shorter.
• Notarization and embassy attestation requirements apply to foreign documents.

Purpose

Keeps DRAP informed of safety and quality problems after a device is on the market so it can act (e.g. recalls).

Who it applies to

Enlistment/registration holders: local manufacturers and importers.

Applicable products

All enlisted or registered devices; record-keeping duties in rule 19(8) are framed for 'new' medical devices.

General requirements

• Keep organized records of clinical data, literature, labelling errors, batch deterioration, batch failures, unexpected side effects and performance failures (rule 19(8))
• Report batch failures, unexpected side effects/injuries and unusual performance failures to the MDB as soon as possible and within 14 days (rule 19(9)(b))
• Inform the MDB within 30 days if the device is withdrawn, banned or restricted for safety reasons in the origin country or the USA, EU, Canada, Japan or Australia (rule 19(10))
• Report within 30 days any adverse reaction reported in reference countries that was not in the application (rule 19(12))
• Importers must ensure regular, adequate supply; issue warranty on Form-5

Typical documentation

• Complaint and adverse-event records; recall procedure under DRAP GDP guidance

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Reports go to the MDB; DRAP also runs a National Pharmacovigilance Centre that accepts adverse-event reports and issues recall alerts for substandard devices.

Important notes

• MDR 2017 defines 'field corrective action' as action by the manufacturer or its authorized agent to reduce a risk of death or serious deterioration in health.

Purpose

Controls export of medical devices from Pakistan, which is relevant to export-oriented instrument makers.

Who it applies to

Establishments exporting medical devices from Pakistan (except small quantities for personal use or for clinical investigation/testing, which have their own permits).

Applicable products

Medical devices covered by the Rules, including reusable surgical instruments (Class A).

Classification

Not class-dependent.

General requirements

• No export without MDB (or authorized officer) approval (rule 27(1))
• No export permit unless the establishment is licensed and the device is enlisted or registered (rule 27(2))
• Keep records of all exports; allow inspection of storage and sampling; withdraw batches from export if directed (rules 31–32)
• Consignments to be accompanied by invoice/other documents as specified (rule 35)

Typical documentation

• Application for export permit on Form-12 with fee per rule 63

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply on Form-12; one application and one permit can cover several devices from the same manufacturer; the permit is issued on Form-13.

Validity and renewal

Export permit valid for three years unless suspended or cancelled; it stays valid pending renewal if renewal is applied for three months before expiry (rule 30).

Important notes

• The forms ask whether a device is 'for export only', but in the 2018 text reviewed, export still required the establishment to be licensed and the device enlisted/registered. No separate export-only exemption was found in DRAP sources reviewed.
• Exporters also need to meet the importing country's own rules (e.g. EU MDR, US FDA).

Purpose

The Medical Devices Law (Royal Decree M/54, 1442H) and its Executive Regulation (SFDA Board decree 3-29-1443) govern the full lifecycle of medical devices in the Kingdom. SFDA issues detailed 'MDS-REQ' requirement documents and 'MDS-G' guidance under them.

Who it applies to

Local manufacturers, foreign manufacturers (through a Saudi Authorized Representative), importers, distributors, warehouses and certain service providers.

Applicable products

Medical devices and IVDs, including accessories and software; borderline products are decided under SFDA's products classification guidance.

Classification

Risk classes A (lowest), B, C and D (highest), using the rules in Annex 5 of MDS-REQ 1 (largely aligned with EU MDR rules).

General requirements

• Establishment licence (MDEL) for each establishment, branch and warehouse (MDS-REQ 9)
• Medical Device Marketing Authorization (MDMA) for each device or device group (MDS-REQ 1)
• Saudi Authorized Representative for overseas manufacturers
• UDI and Saudi-DI database listing (MDS-REQ 7)
• Post-market surveillance and reporting to the NCMDR (MDS-REQ 11)
• Storage/transport (MDS-REQ 12), inspections/QMS (MDS-REQ 10) and advertising approval (MDS-REQ 8)

Typical documentation

• Applications are filed in SFDA's GHAD electronic system
• Technical documentation per Annex 3/4 of MDS-REQ 1
• ISO 13485:2016 QMS evidence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Register the establishment and obtain the relevant licence in GHAD, then apply for MDMA for each device; list UDI data in Saudi-DI; import shipments are cleared against valid licences and MDMA.

Important notes

• SFDA establishment licensing and product marketing authorization are separate; both are needed before devices circulate.
• SFDA documents are revised frequently; always check the version date on sfda.gov.sa.

Purpose

Under Article 6 of the Medical Devices Law no establishment may carry out regulated activities unless registered and licensed; MDS-REQ 9 sets the conditions.

Who it applies to

Saudi legal entities acting as local manufacturer, authorized representative, importer/distributor, warehouse, testing lab, conformity assessment body, clinical-trial verification, radiation QA, technical consultation or maintenance provider.

Applicable products

All medical devices; optics importers/distributors have a specific licence type.

Classification

Not device-class based; SFDA assigns an establishment category (A–D) from the GHAD questionnaire (activities, staff, coverage, device groups), which sets the QMS evidence required.

General requirements

• Saudi legal entity with other required government licences
• GHAD account and establishment number; application via GHAD or the Saudi Business Center
• Manufacturers/importers/distributors in establishment categories A and B: ISO 13485 certificate (SFDA.MD/GSO ISO 13485) from an SFDA-accredited CAB
• ARs/importers/distributors in categories C and D: documented QMS evidence or an SFDA inspection report
• Qualified authorized person to deal with SFDA; local manufacturers need full-time technical and quality managers
• Importers/distributors: warehouse licence or licensed third-party storage, documented storage/transport and traceability procedures, AR details for each overseas manufacturer
• Keep records for at least 5 years; give documents to SFDA within 10 days of request; notify changes within 10 days

Typical documentation

• Commercial registration and other authority licences
• QMS certificate or inspection evidence
• Manufacturer data and signed declarations of conformity (importers)
• Procedures for storage, transport and tracking

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply in GHAD; SFDA reviews and may inspect, then issues the licence; renewal can be requested 60 days before expiry.

Validity and renewal

SFDA states licences are issued for one year or renewable similar periods; Annex 2 of MDS-REQ 9 lists licence periods that vary by establishment type.

Important notes

• A licence does not authorize sale of any device – each device also needs an MDMA.
• Importers/distributors must ensure each device has a valid MDMA, a manufacturer-signed DoC and a UDI.
• Fees exist in Annex 2 of MDS-REQ 9; not reproduced here.

Purpose

The AR acts for the overseas manufacturer in dealings with SFDA, including marketing authorization and post-market duties.

Who it applies to

Manufacturers located outside Saudi Arabia and the Saudi legal entities appointed as their ARs.

Applicable products

All medical devices of the represented manufacturer; only one AR per manufacturer for the same type or general group of devices.

General requirements

• Saudi legal entity holding an SFDA AR licence (part of MDEL) for each manufacturer represented
• Written, documented agreement with the manufacturer covering delegated activities, device types, PMS compliance and termination rules
• QMS evidence or SFDA inspection report per establishment category
• Authorized person with relevant qualification
• Annually confirm the accuracy of submitted information

Typical documentation

• Signed AR agreement / mandate from the manufacturer
• AR licence application in GHAD

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

The Saudi entity obtains an AR licence in GHAD for the manufacturer, then can apply for MDMA on its behalf.

Important notes

• AR responsibility continues after termination until a new AR is appointed or devices are no longer on the market or with users.
• AR must report incidents outside KSA affecting devices traded in KSA, cooperate in PMS, notify NCMDR of supply shortages of high-risk devices and ensure after-sales service and spare parts.

Purpose

Confirms the device meets SFDA's Essential Principles of Safety and Performance and is registered before it is made available, paid or free.

Who it applies to

Local manufacturers (holding a manufacturing licence) and overseas manufacturers via their licensed AR.

Applicable products

All medical devices and IVDs. Devices may be bundled/grouped in one application per SFDA bundling criteria (now also in guidance MDS-G-028, 2026).

Classification

Classes A–D per Annex 5 of MDS-REQ 1; the class drives evidence depth.

General requirements

• Compliance with Essential Principles (Annex 1, or Annex 2 for IVDs)
• Technical documentation per Annex 3/4, held and kept updated by the manufacturer
• QMS to ISO 13485:2016 (or identical adopted standard)
• Applicant licence (manufacturer or AR) before applying
• Notify SFDA of significant changes within 10 days and non-significant changes within 30 days
• Renew before expiry; renewal can be requested 90 days before expiry

Typical documentation

• Application form in GHAD – Marketing Authorization Services
• For low-risk devices (except IVDs, sterile, measuring, reusable surgical instruments and novel devices): device description and specification, information supplied by the manufacturer, Essential Principles checklist and evidence, risk management file, PMS plan and report
• Other devices: full technical documentation (design and manufacturing, verification/validation incl. clinical evidence, PMS, PSUR where applicable)
• Declaration of Conformity (Annex 14)
• SFDA may request the full technical file at any time, to be supplied within 10 days

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit in GHAD with fees; SFDA reviews and, once satisfied, issues an Arabic/English MDMA certificate showing the device(s), Medical Device National Listing Numbers and validity period.

Validity and renewal

The validity period is stated on each MDMA certificate; SFDA refers to its circulars for fees, review times and validity.

Important notes

• Reusable surgical instruments are expressly excluded from the reduced low-risk dossier in MDS-REQ 1, so plan for fuller technical documentation even though they are Class A.
• Innovative devices may be exempted from some technical-documentation requirements via the Innovative Medical Device Summary Form (Annex 11).

Purpose

Determines the device class used in MDMA applications, UDI phasing and evidence requirements.

Who it applies to

Manufacturers, who must classify each device under Annex 5 of MDS-REQ 1.

Applicable products

Non-IVD devices (rules in Annex 5); IVDs have separate classification rules.

Classification

Class A (low) to Class D (high). Example rules: non-invasive devices are Class A unless another rule applies; transient surgically invasive devices are higher class unless they are reusable surgical instruments, which are Class A.

General requirements

• Classify using Annex 5 rules and definitions (duration, invasiveness, active/non-active, body system)
• Where several rules apply, the strictest applies

Typical documentation

• Classification rationale within technical documentation

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Manufacturer self-classifies; SFDA verifies during MDMA review.

Important notes

• SFDA defines a reusable surgical instrument as one intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to an active device, intended to be reused after appropriate reprocessing.

Purpose

Enables identification and traceability of devices across the Saudi supply chain.

Who it applies to

Manufacturers or their ARs (Saudi-DI submission); importers/distributors must check that UDI is present.

Applicable products

Devices placed on the Saudi market and not exempted from marketing authorization; phased by risk class.

Classification

Compliance dates are phased by risk class (A–D) per SFDA announcement.

General requirements

• UDI (UDI-DI + UDI-PI such as lot, serial, expiry, manufacturing date) in human-readable and machine-readable (AIDC) form on label/packaging
• Submit device data (incl. risk class, GMDN, maximum reuses, storage conditions) to the Saudi-DI database; update within 10 days for changes not needing a new UDI-DI
• Reusable devices reprocessed between patients must carry a permanent Direct Marking (DM) UDI readable through their intended life
• Labels per MDS-REQ 1 Annex 1 section 23 (name, manufacturer, UDI carrier, expiry, sterile state etc.); lay-user information in Arabic and English; SFDA logo not allowed on labels; reusable devices need reprocessing instructions

Typical documentation

• Saudi-DI database records
• Labels and IFU (e-IFU allowed under Annex 10 conditions)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Assign UDIs (via an issuing agency such as GS1/HIBCC/ICCBBA), apply carriers, and submit data on udi.sfda.gov.sa before the class compliance date.

Important notes

• DM exemptions exist if marking would affect safety/performance, is not technically feasible, the device is already marked, it is only cleaned (not disinfected/sterilized) between uses, or it is single-patient use – the manufacturer must document the justification.
• Devices imported before a compliance date may be distributed for one year after that date.
• IFU may be omitted for Class A and B devices that can be used safely without them.

Purpose

Sets reporting, investigation, safety-alert and field safety corrective action duties after a device is on the Saudi market.

Who it applies to

Manufacturers, authorized representatives and healthcare providers (and licensed establishments, who must comply with REQ 11).

Applicable products

All medical devices on the Saudi market.

General requirements

• Report adverse events/complaints: within 2 days if a serious public health threat; within 10 days if it may cause or contribute to death or serious injury; within 30 days otherwise
• Respond to NCMDR follow-up queries within 5 days
• Submit initial, follow-up and final investigation reports; final report deadlines of 15, 30 or 60 days depending on severity
• Report FSCAs/safety notices affecting KSA within 2 days of the FSCA letter date and implement per NCMDR-approved plan
• Report violating devices and submit a corrective plan within 5 days
• Appoint a contact officer with the NCMDR

Typical documentation

• MD reporting form, investigation reports, FSCA letters and closure reports
• PMS plan and report within the technical documentation

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Reports are submitted to the NCMDR; SFDA may issue safety alerts and require recalls or other corrective actions.

Purpose

EDE was set up by Federal Decree-Law No. 28 of 2023 and describes itself as the sole federal authority regulating medical and pharmaceutical products, including medical devices. Federal Decree-Law No. 38 of 2024 governs medical products, pharmacists and pharmaceutical establishments.

Who it applies to

Foreign and local manufacturers (registered with EDE), and UAE-licensed medical warehouses, local manufacturers and marketing offices that apply for device marketing authorizations and import.

Applicable products

Medical devices and reagents placed on the UAE market; EDE service pages refer to device Classes I–IV.

Classification

EDE service pages refer to Classes I, II, III and IV, with safety and effectiveness data required for Classes III and IV.

General requirements

• Registration of the manufacturer (and marketing-rights holder) with EDE
• Marketing authorization (registration) of each medical device with EDE
• Applicant must be an EDE-licensed medical warehouse, local manufacturer or marketing office
• Free sale/registration certificate from country of origin, attested by the UAE embassy
• Post-marketing surveillance information within the dossier

Typical documentation

• See the separate EDE manufacturer-registration and device marketing-authorization entries

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Register the manufacturer through a local licensed entity, then submit device marketing authorization applications on the EDE portal using UAE Digital ID.

Validity and renewal

EDE service pages state five years for both manufacturer registration and device marketing authorization.

Important notes

• MOHAP announced that requests for transferred services are submitted through the EDE portal from 29 December 2025; 44 services moved fully to EDE and 13 partially, including licensing of pharmaceutical facilities.
• Do not assume a federal EDE authorization covers every emirate-level requirement: DoH Abu Dhabi and DHA regulate healthcare facilities and have their own reporting and procurement rules.
• Older MOHAP device-registration pages and guides may be out of date.

Purpose

Product-level authorization for import and sale of a medical device at federal level.

Who it applies to

EDE-licensed medical (drug) warehouses, local manufacturers and marketing offices acting for the manufacturer/marketing-rights holder, both of which must be registered with EDE first.

Applicable products

Medical devices and reagents, Classes I–IV per EDE service pages.

Classification

Classes I–IV; Class III and IV require safety and effectiveness data.

General requirements

• Manufacturer and marketing-rights holder registered with EDE
• Applicant holds valid EDE licence
• Laboratory analysis, pricing or samples may be required for certain devices
• Changes to registered data are handled via EDE's amendment certificate service

Typical documentation

• Signed and stamped registration application
• Valid EDE manufacturer registration certificate
• Free sale or registration certificate from origin-country authority, attested by the UAE embassy
• Agency agreement or authorization letter between company and local agent
• Conformity or marketing certificate (e.g. EC certificate, 510(k), PMA) depending on class
• Registrations in other countries; post-marketing surveillance information
• Product data: description, models/sizes, accessories, intended use, contraindications, warnings, IFU and packaging/leaflet images
• Manufacturer's declaration of conformity
• Safety and effectiveness data for Class III/IV; special certificates e.g. for animal-derived materials

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Log in with UAE Digital ID, complete the form, attach documents, pay online and submit; complete any required lab steps; EDE committee approves and issues the certificate.

Validity and renewal

Five years from committee approval, per the EDE service page; renewal is a separate EDE service.

Important notes

• EDE publishes fees and a target processing time on the service page; they are not reproduced here and may change.
• The checklist refers to EU 'EC' certificates; it is unclear how EU MDR certificates are referenced – confirm with EDE.

Purpose

Site-level registration of the manufacturer that must precede product marketing authorization.

Who it applies to

Manufacturers of medical devices, applying through an EDE-licensed medical warehouse/local agent named in an authorization letter.

Applicable products

All medical device manufacturers supplying the UAE.

General requirements

• Applicant is an EDE-licensed medical warehouse
• Manufacturer meets the requirements of EDE's registration committee

Typical documentation

• Original authorization letter on company letterhead naming the local person/entity, notarized
• Valid ISO 13485 certificate, notarized
• Valid manufacturing/work licence from the origin-country authority, attested by the UAE embassy
• List of products manufactured or assembled at the site
• Detailed company profile

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit online via EDE with UAE Digital ID and pay fees; EDE issues a registration certificate once requirements are met.

Validity and renewal

Five years per EDE renewal service page.

Important notes

• Document list above is from EDE's renewal service page for medical devices; the initial registration page was not located but renewal is stated to follow the same procedure.

Purpose

Ensures a UAE-based licensed entity is responsible for import, storage and regulatory submissions.

Who it applies to

UAE companies importing, storing or marketing medical devices on behalf of manufacturers.

Applicable products

All registered medical devices.

General requirements

• Valid licence as a medical warehouse, local manufacturer or marketing office recognized by EDE
• Agency agreement/authorization from the manufacturer

Typical documentation

• Establishment licence; agency agreement

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Obtain the establishment licence before applying for manufacturer registration and product marketing authorization.

Important notes

• MOHAP's announcement lists licensing of pharmaceutical facilities among services only partially transferred to EDE, so the issuing body for a given establishment licence may depend on emirate and service.

Purpose

Emirate health authorities license healthcare facilities and professionals and set standards for use, reporting and reimbursement of devices in their emirate.

Who it applies to

Healthcare facilities and professionals; DoH's medical device reporting standard also names manufacturers, importers, distributors and registrants of devices sold in Abu Dhabi.

Applicable products

Devices supplied to or used in facilities in the relevant emirate.

General requirements

• Abu Dhabi: DoH's regulator manual requires medical products to be on an approved list before placement on the Abu Dhabi market, with ongoing safety monitoring
• Abu Dhabi: DoH Standard on Medical Device Reporting covers incidents and adverse events, including duties for manufacturers, importers, distributors and registrants
• Dubai: DHA licenses health facilities (Sheryan portal); facilities may be initiated with DHA, Dubai Economy & Tourism or free-zone authorities

Typical documentation

• Per DoH/DHA standards and facility procurement requirements

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Federal EDE registration is obtained first; emirate-specific obligations then apply through facility licensing, procurement and reporting channels.

Important notes

• Requirements are not identical across emirates; check the authority in each emirate where devices will be sold or used.
• DoH's Durable Medical Equipment policy (for payers/providers) asks for supplier conformity declarations, UDI/serial identifiers and Arabic/English IFU for certain DME.

Purpose

RDC 751/2022 (in force 1 March 2023) sets risk classification, notification and registration procedures, changes, revalidation, cancellation and labelling/IFU rules. B-GMP is set by RDC 665/2022.

Who it applies to

Brazilian legal entities (manufacturers or importers) that hold the notification or registration ('detentor') and the foreign manufacturers they represent.

Applicable products

Medical devices other than IVDs (IVDs have separate rules).

Classification

Class I (low), II (medium), III (high), IV (maximum risk), by rules in Annex I of RDC 751 (EU MDR-style).

General requirements

• Notification (Class I and II) or registration (Class III and IV) before marketing
• Holder must be a Brazilian public or private legal entity responsible for the device in Brazil
• Compliance with B-GMP (RDC 665/2022); ANVISA B-GMP certificate needed for registration (Class III/IV)
• INMETRO/SBAC conformity certificate for devices under compulsory certification
• Portuguese petition forms, IFU/manuals and labels

Typical documentation

• Petition forms, manufacturer authorization letter (imports), technical dossier, B-GMP certificate (III/IV), SBAC certificate where applicable

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Determine class, prepare documents and pay the fee, then file the notification or registration petition with ANVISA.

Validity and renewal

Registration is valid for 10 years from publication in the Diário Oficial da União and can be revalidated for equal periods (Art. 11).

Important notes

• Art. 40 of RDC 751 was revoked by RDC 777/2023; check for later amendments.

Purpose

Simplified market access route for lower-risk devices.

Who it applies to

The Brazilian holder (manufacturer or importer) of Class I or II devices.

Applicable products

Class I and II medical devices, including reusable surgical instruments (Class I under Rule 6).

Classification

Class I and II.

General requirements

• Pay the applicable fee and submit the notification form from the ANVISA portal
• Imported devices: legal manufacturer's declaration (consularized or apostilled; in Portuguese, English or Spanish or with sworn translation; max two years old if undated validity) authorizing the applicant and confirming knowledge of and compliance with B-GMP (RDC 665/2022)
• SBAC conformity certificate where compulsory
• Holder keeps the technical dossier and must provide it on request

Typical documentation

• Notification form; manufacturer declaration (imports); SBAC certificate if applicable; evidence of compliance with device-specific technical regulations

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

No technical analysis is done before the product is considered regularized; ANVISA may carry out documentary or inspection checks at any time.

Important notes

• Maintenance of notification depends on continued B-GMP compliance and meeting essential safety and performance requirements.
• An ANVISA B-GMP certificate is not listed as a notification requirement in RDC 751, unlike registration.

Purpose

Pre-market review for high- and maximum-risk devices.

Who it applies to

The Brazilian registration holder (manufacturer or importer).

Applicable products

Class III and IV medical devices.

Classification

Class III and IV.

General requirements

• Registration form and fee
• Technical dossier (Chapter VII of RDC 751)
• Imported devices: manufacturer authorization declaration and proof of registration/free sale in the country of manufacture or sale (consularized/apostilled, max two years old where undated)
• ANVISA B-GMP certificate, or proof of having applied for it (approval waits for the certificate)
• SBAC certificate where compulsory

Typical documentation

• Technical dossier, labels and IFU in Portuguese, B-GMP certificate, free sale/registration proof

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

ANVISA reviews the dossier and may request more information; grant is published in the Diário Oficial da União once the B-GMP certificate has been published.

Validity and renewal

10 years from publication in the DOU, renewable for equal periods (Art. 11).

Important notes

• Petitions missing mandatory documents can be refused summarily without a technical query.

Purpose

Ensures a legally responsible entity in Brazil for each marketed device.

Who it applies to

Foreign manufacturers and the Brazilian companies that represent them.

Applicable products

All notified or registered medical devices.

General requirements

• Holder is a Brazilian public or private legal entity, manufacturer or importer, responsible for the device in Brazil
• Signed, consularized/apostilled authorization from the legal manufacturer to represent and sell its products
• Holder communicates changes to ANVISA and keeps the technical dossier
• Holder needs an ANVISA company operating authorization (AFE) – referenced in RDC 751 change rules

Typical documentation

• Manufacturer authorization declaration; holder's AFE

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

The foreign manufacturer appoints the holder, which files notifications/registrations in its own name.

Important notes

• Many foreign manufacturers use an independent holder (rather than a distributor) so they can change distributors without moving registrations; this is a commercial practice, not a legal requirement.

Purpose

Sets the quality system requirements manufacturers must meet to keep devices notified or registered in Brazil.

Who it applies to

Domestic and foreign manufacturers of devices placed on the Brazilian market.

Applicable products

All classes; certificate route required for registration (Class III/IV); Class I/II manufacturers declare compliance.

Classification

Certificate needed for Class III and IV registration.

General requirements

• Implement a QMS meeting RDC 665/2022
• For Class III/IV: obtain an ANVISA B-GMP certificate (application protocol accepted to start review)

Typical documentation

• B-GMP certificate or proof of application; manufacturer's B-GMP declaration for notifications

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Manufacturer applies to ANVISA for B-GMP certification; ANVISA may inspect or use other mechanisms (e.g. MDSAP reports) under its rules.

Important notes

• Continued notification/registration depends on ongoing B-GMP compliance (RDC 751 Art. 10 §7).

Purpose

Sets how class is determined and what labels and instructions must contain.

Who it applies to

Manufacturers and Brazilian holders.

Applicable products

All medical devices under RDC 751.

Classification

Rule 6: transient surgically invasive devices are Class II unless they are reusable surgical instruments (Class I) or meet higher-risk conditions (e.g. heart/central circulatory/CNS contact – Class IV).

General requirements

• Apply Annex I rules; where several rules apply, use the strictest
• Standalone software (SaMD) classified on its own; driving software takes the class of the device
• Portuguese labels and IFU, including holder name and address, and, where applicable, manufacturing date and expiry
• For reusable devices: reprocessing information (cleaning, disinfection, packaging, re-sterilization method) and any limit on reuses

Typical documentation

• Label artwork and IFU in Portuguese submitted with petitions

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Class is declared in the petition; ANVISA may challenge it.

Important notes

• RDC 751 defines reusable surgical instruments to include instruments that may or may not connect to an active device – wider than some other jurisdictions' definitions.

Purpose

The Medical Devices Act, its Enforcement Decree and Rules, and MFDS notices regulate product authorization, business licensing, GMP and post-market control.

Who it applies to

Korean manufacturers and importers; overseas manufacturers reach the market through a Korean licensed importer (or local licence holder).

Applicable products

Medical devices and IVDs (MFDS lists 2,109 non-IVD and 225 IVD item categories by class).

Classification

Class I (very low risk, e.g. stethoscope, operating table), II (low, e.g. MRI, pulse oximeter), III (moderate, e.g. silk suture), IV (high, e.g. coronary stent, IOL); GHTF/IMDRF-harmonized.

General requirements

• Product notification (Class I), certification (most Class II) or approval (new Class II, Class III, IV)
• Manufacturing business licence or import business licence from the regional MFDS office
• Quality management system (KGMP) requirements
• Tracking of designated high-risk devices and post-market obligations

Typical documentation

• Technical documents for certification/approval; clinical trial reports where intended use, mechanism or materials differ significantly from existing devices

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Business licence and first product licence are processed at the same time; the business licence is issued after the product licence is approved.

Important notes

• Some Class I/II devices go directly to MFDS: those needing clinical reports, digital healthcare devices, devices with undefined nomenclature/classification, and drug-device combinations.

Purpose

Product-level authorization of each device before manufacture for sale or import.

Who it applies to

Licensed manufacturers and importers (the importer applies for imported devices).

Applicable products

All classes; routing exceptions apply to devices needing clinical data, digital healthcare devices, unclassified devices and drug-device combinations.

Classification

Class I: notification; Class II: certification (substantially equivalent/modified) or approval (new); Class III/IV: approval.

General requirements

• Technical documents (specifications, test reports, etc.) for certification and approval
• Clinical trial reports where differences could significantly affect safety and efficacy
• QMS (KGMP) compliance as part of the process

Typical documentation

• Application with technical documentation; clinical data where required

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit to the designated body (Class I/II) or MFDS (new Class II, III, IV); MFDS publishes indicative review times on its English pages.

Important notes

• Fees and statutory review periods are not reproduced here; check MFDS.

Purpose

Establishment-level licence for Korean manufacturers and importers.

Who it applies to

Korean manufacturers and importers (foreign manufacturers supply through a licensed Korean importer).

Applicable products

All medical devices.

General requirements

• Hold at least one product licence (processed together with the business licence)
• Applicant fitness certificates (medical certificates on mental health and on drug/toxic substance addiction)
• Qualified quality manager
• Records of manufacture/import quantities and sales by product, model and batch for tracked devices

Typical documentation

• Medical fitness certificates; quality manager qualification proof

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply to the regional MFDS office; the business licence is issued after the product licence is approved.

Important notes

• Third-party sources describe a 'Korea Licence Holder' model for overseas manufacturers; MFDS's English page describes this through the importer licence.

Purpose

Sets ISO 13485-based quality system standards for manufacturers and importers (including foreign manufacturing sites of imported devices).

Who it applies to

Manufacturers and importers of medical devices in Korea.

Applicable products

Devices of all classes per the MFDS approval flowchart; exemption arrangements for low-risk classes were not confirmed.

General requirements

• Quality system meeting MFDS medical device GMP standards
• GMP audit/inspection as specified for the device class

Typical documentation

• Quality manual and records; GMP certificate

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply for GMP assessment; certificates are issued after a successful audit.

Important notes

• MFDS publishes an English compilation of its Medical Device GMP Regulations (updated February 2026).

Purpose

Regulates supply of medical devices in Singapore through product registration and dealer licensing.

Who it applies to

Companies that manufacture, import, wholesale or register medical devices in Singapore.

Applicable products

Medical devices including IVDs and standalone medical mobile apps.

Classification

Class A (lowest) to Class D (highest), based on intended purpose, invasiveness, duration and technology.

General requirements

• Classify the device.
• Class B, C, D: register on the Singapore Medical Device Register before supply.
• Class A: exempt from registration but manufacturer/importer files a product notification in SHARE.
• Hold the relevant dealer's licence(s) and a QMS appropriate to the activity.

Typical documentation

• Registration dossier (Class B-D)
• Reference regulator approvals for abridged/expedited routes
• Dealer licence QMS evidence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Obtain dealer licences, register or notify devices via HSA's SHARE system, then meet post-market duties.

Important notes

• HSA's public Class A listing includes reusable surgical instruments such as needle holders, but classification must be confirmed for each device.

Purpose

Pre-market evaluation of device safety, quality and performance.

Who it applies to

Registrants of Class B-D devices; manufacturers/importers notifying Class A devices.

Applicable products

Class B-D devices. Class A devices are exempt from registration but must be notified.

Classification

Class A exempt; Class B, C, D registered.

General requirements

• Full evaluation where no reference regulator approval exists.
• Abridged evaluation with at least one reference regulator approval (TGA, EU notified body, Health Canada, Japan MHLW, US FDA) for the same labelled use.
• Expedited (Class C ECR, Class D EDR) or immediate (Class B IBR) routes where conditions are met.
• Approvals for devices exempted as Class I/II by reference agencies do not qualify as reference evidence.

Typical documentation

• CSDT-format dossier
• Reference regulator approval letters/certificates
• Labelling

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit through SHARE; fees and turnaround depend on route (see HSA fees page).

Purpose

Controls who may deal in medical devices and ensures quality systems in the supply chain.

Who it applies to

Local manufacturers, importers and wholesalers of medical devices.

Applicable products

All device classes, subject to exemptions in the regulations.

General requirements

• Apply through SHARE for each licence type needed.
• Establish and maintain an appropriate QMS.
• Notify HSA of changes (e.g. risk classes handled, QMS certification, sites).
• Renew licences on time.

Typical documentation

• QMS certification evidence
• Site details

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply, maintain and renew in SHARE.

Important notes

• Foreign manufacturers usually supply through a Singapore-based importer/registrant.

Purpose

Regulates medical devices and the establishments dealing with them in Malaysia.

Who it applies to

Local manufacturers, authorised representatives of overseas manufacturers, importers and distributors (not retailers).

Applicable products

Medical devices and IVDs; exemptions exist (e.g. export-only, personal use, certain demonstration/education uses) under exemption orders.

Classification

Class A (lowest), B, C, D (highest).

General requirements

• Register the device via MDA's MeDC@St system after conformity assessment.
• Overseas manufacturers appoint a Malaysian authorised representative with a letter of authorisation.
• Establishments hold an establishment licence before importing, exporting or placing registered devices on the market.
• Meet post-market duties (distribution records, complaints, incident reporting, recalls).

Typical documentation

• Registration dossier (CSDT)
• Conformity assessment evidence
• Letter of authorisation
• Establishment licence application

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Appoint AR, obtain conformity assessment (CAB for Class B-D, or verification route), register device, obtain establishment licence.

Important notes

• Export-only devices are exempt from registration but need an exemption notification.

Purpose

Pre-market control that devices meet Malaysian safety and performance requirements.

Who it applies to

Local manufacturers and authorised representatives of foreign manufacturers.

Applicable products

All classes; Class A applications go directly to MDA; export-only devices are exempt from registration.

Classification

Class A: exempt from CAB conformity assessment (Medical Device (Exemption) Order 2024). Class B-D: CAB conformity assessment or verification based on reference approvals (MDA/GD/0070).

General requirements

• Prepare a registration dossier with essential principles conformity evidence.
• Class B-D: obtain conformity assessment by a registered CAB, or use the verification process where eligible.
• Submit and pay fees via MeDC@St.

Typical documentation

• CSDT dossier
• Declaration of conformity
• CAB report or reference approvals
• Labelling

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit application in MeDC@St; MDA evaluates and issues registration.

Purpose

Controls and holds accountable the companies in the device supply chain.

Who it applies to

Manufacturers, authorised representatives of overseas manufacturers, importers and distributors (retailers excluded).

Applicable products

All registered devices handled by the establishment.

General requirements

• Apply for the licence type matching the activity.
• ARs hold a letter of authorisation from the foreign manufacturer.
• Comply with good distribution practice requirements as applicable.
• Renew the licence and pay fees.

Typical documentation

• Licence application
• Letter of authorisation (ARs)
• Distribution practice evidence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply via MDA's online system; renew before expiry.

Important notes

• MDA/GD/0027 (2022) lists fees by licence type; fees can change - check MDA before quoting.

Purpose

Regulates placing medical devices and IVDs on the Swiss market under the Therapeutic Products Act.

Who it applies to

Manufacturers, Swiss authorised representatives (CH-REP), importers and distributors in Switzerland.

Applicable products

Medical devices and IVDs; legacy devices with EU Directive certificates may continue under transitional periods aligned with the EU (31 Dec 2027 high risk / 31 Dec 2028 medium-low risk per FOPH).

Classification

Same classes as EU MDR (I, IIa, IIb, III) and IVDR (A-D).

General requirements

• Meet MedDO/IvDO requirements equivalent to EU MDR/IVDR, including conformity assessment and conformity marking (CE marking based on EU notified body certificates is recognised).
• Foreign manufacturers appoint a Swiss authorised representative (CH-REP).
• Importers and CH-REPs register as economic operators (CHRN).
• Register devices in swissdamed (mandatory from 1 July 2026).

Typical documentation

• EU/Swiss declaration of conformity
• Technical documentation available via CH-REP
• Certificates where applicable
• Labelling identifying CH-REP and importer

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Complete conformity assessment (EU notified body certificates recognised), appoint CH-REP, register actors and devices in swissdamed, maintain vigilance with Swissmedic.

Important notes

• Swiss conformity assessment bodies are not recognised by the EU for CE marking since the MRA was not updated.

Purpose

Provides a Swiss-based party responsible for formal and safety-related aspects of foreign manufacturers' devices.

Who it applies to

Foreign manufacturers placing devices on the Swiss market, their CH-REPs and Swiss importers.

Applicable products

All medical devices and IVDs from foreign manufacturers.

General requirements

• Written mandate between foreign manufacturer and CH-REP (mandates managed in swissdamed).
• CH-REP and importer register to obtain a Swiss single registration number (CHRN).
• CH-REP keeps technical documentation and DoC available to Swissmedic and cooperates on vigilance.

Typical documentation

• CH-REP mandate
• CHRN
• Access to technical documentation and DoC

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Appoint CH-REP, record mandate in swissdamed, label with CH-REP details.

Important notes

• If a CH-REP becomes inactive in swissdamed, its mandates are treated as no longer valid.

Purpose

Creates a Swiss database of devices on the market, replacing the former notification obligation.

Who it applies to

Manufacturers via their Swiss actors (manufacturers based in Switzerland or CH-REPs), and system/procedure pack producers.

Applicable products

MedDO devices and legacy devices still placed on the market; notification (not registration) still applies to custom-made, repackaged/relabelled and in-house devices.

Classification

All classes.

General requirements

• Register devices and system/procedure packs in swissdamed.
• Registration can be completed retrospectively until 31 December 2026.
• Immediate registration (no transition) for devices with a reportable serious incident, FSCA or trend.

Typical documentation

• UDI/device data
• Actor CHRN

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Swiss actor registers devices in swissdamed's device module.

Important notes

• Swiss registration is separate from EUDAMED registration.

Purpose

The Medicines and Related Substances Act 101 of 1965 and the Regulations relating to Medical Devices and IVDs (Government Gazette 40480, 9 December 2016) provide for licensing of establishments, classification, registration and vigilance.

Who it applies to

Manufacturers, distributors (importers/exporters) and wholesalers of medical devices and IVDs in South Africa.

Applicable products

Medical devices and IVDs; Class A non-sterile, non-measuring devices are exempt from establishment licensing.

Classification

Classes A (low) to D (high) for devices and IVDs, per SAHPRA guideline SAHPGL-MD-04.

General requirements

• Establishment licence (manufacturer, distributor or wholesaler) before manufacturing, importing, exporting, distributing or selling
• Authorised Representative – a natural person based in South Africa
• ISO 13485 certification at licence renewal for manufacturers and distributors
• Product registration once SAHPRA calls up device types/classes

Typical documentation

• Licence application per SAHPRA guidelines (SAHPGL-MD-06 and Q&A SAHPGL-MD-07)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply for the relevant establishment licence; product registration will follow SAHPRA's published call-up plan.

Important notes

• A valid SAHPRA licence is required to bid for national and provincial tenders.
• Since 31 March 2020, acknowledgement letters are no longer accepted in place of a licence.

Purpose

Controls who may manufacture, import, export, distribute or sell medical devices in South Africa.

Who it applies to

Manufacturer licence: manufacture, pack, label, service, import, export, distribute. Distributor licence: import, export, distribute. Wholesaler licence: buy locally and sell to retailers – no import/export.

Applicable products

Class B, C, D devices and IVDs, and Class A devices that are sterile or have a measuring function. Class A non-sterile, non-measuring devices are exempt.

Classification

Licence scope depends on device class and activity.

General requirements

• Appoint an Authorised Representative (natural person based in South Africa)
• Quality management system; ISO 13485:2016 certificate from an accredited body at renewal for manufacturers and distributors
• For Class C and D: evidence of prior approval/registration by a recognised foreign regulator (per SAHPRA licensing guideline)

Typical documentation

• Application per SAHPGL-MD-06 with listed device details and QMS evidence

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit the licence application to SAHPRA; licence is granted after review (and inspection where required).

Important notes

• Non-sterile reusable surgical instruments such as scissors and artery forceps are Class A, so their manufacturers/distributors may fall under the Class A exemption; supplying them sterile removes the exemption.

Purpose

Sets the rules used to classify devices for licensing and future registration.

Who it applies to

Manufacturers, distributors and wholesalers.

Applicable products

Medical devices and IVDs (separate IVD rules).

Classification

Class A (low), B (low–moderate), C (moderate–high), D (high). Rule 6(b): a reusable surgical instrument is Class A.

General requirements

• Classify using SAHPGL-MD-04 rules (invasiveness, duration, active/non-active, body site)

Typical documentation

• Classification rationale for each device in licence applications

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Applicant classifies; SAHPRA may verify.

Important notes

• Single-use and other surgically invasive transient-use devices are generally higher than Class A under Rule 6.

Purpose

Explains the current status of product-level registration so buyers do not assume a 'SAHPRA registration' exists for most devices.

Who it applies to

Future applicants for device registration.

Applicable products

All devices once called up; IVDs may use WHO prequalification and the WHO Collaborative Registration Procedure.

Classification

Phasing by device type and class is planned.

General requirements

• None in force for general product registration at the time of verification (per SAHPRA page)

Assessment process

SAHPRA will publish a Registration Call-Up Plan; reliance on approvals from recognised jurisdictions (e.g. Australia, US, EU, Brazil, Canada, Japan) is proposed.

Important notes

• Until call-up, compliance is shown mainly through the establishment licence held by the local manufacturer/distributor.

Purpose

The General Health Law (LGS), the Health Supplies Regulation (RIS), Mexican Official Standards (NOMs) and the FEUM Medical Device Supplement govern production, import, sale and distribution of medical devices.

Who it applies to

Mexican manufacturers, importers/distributors and the foreign manufacturers they represent.

Applicable products

Medical equipment, prostheses/orthoses, diagnostic agents, dental supplies, surgical and wound-care materials, hygienic products and software as a medical device. Items on COFEPRIS's published low-risk list do not need a registro sanitario.

Classification

Class I (known, proven safe, generally not introduced into the body), Class II (may vary in material, generally introduced <30 days), Class III (new or introduced >30 days) – RIS Art. 83; FEUM Appendix II gives detailed criteria.

General requirements

• Registro Sanitario under RIS Art. 82 for production, sale and distribution
• Establishment operating notice (aviso de funcionamiento) and sanitary responsible person (responsable sanitario)
• Spanish labelling per NOM-137-SSA1
• GMP per NOM-241-SSA1 (domestic) or equivalent evidence for foreign sites

Typical documentation

• See Registro Sanitario entry

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Check whether the product is on the low-risk list; identify category and class; file the registration (homoclave COFEPRIS-04-001-A/B/C) with the class checklist.

Validity and renewal

COFEPRIS states registrations have had a five-year validity since 2005, extendable under Ministry of Health rules.

Important notes

• Registrations are issued to the Mexican applicant, which therefore controls the registration.

Purpose

The authorization that allows a domestic or foreign device to be distributed and sold in Mexico.

Who it applies to

Mexican-established applicants: domestic manufacturers (Modalidad A), importers of foreign-made devices (B) and contract-manufactured domestic products (C).

Applicable products

Class I, II and III devices, and software as a medical device, unless on the low-risk exemption list.

Classification

Separate COFEPRIS checklists for Class I, II, III and SaMD; technical/clinical evidence grows with class.

General requirements

• Application form, fee payment and legal representative established in Mexico
• Copy of establishment operating notice and sanitary responsible person (professional licence)
• Spanish label/counter-label drafts per NOM-137; sterile reusable devices must state the re-sterilization method
• Free Sale Certificate or equivalent from the origin authority (authenticated; max 30 months old if no expiry)
• GMP certificate: COFEPRIS GMP for domestic sites; for foreign sites, origin-authority GMP or equivalents such as ISO 13485 or CE certificate
• Letter of representation from the legal manufacturer if it is not the applicant's parent/affiliate
• Technical, scientific and clinical information per class checklist

Typical documentation

• COFEPRIS class checklist documents; maquila (contract manufacturing) agreement where applicable

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Submit under the correct homoclave and modality with the class checklist; COFEPRIS reviews and issues the registration number.

Validity and renewal

Five years per COFEPRIS guide, with extension (prórroga) under Ministry of Health rules.

Important notes

• Use the low-risk list (Acuerdo published in the DOF) to confirm whether a simple instrument needs registration – not verified here for specific surgical instruments.

Purpose

Identifies the Mexican establishment and the professional responsible for sanitary compliance; required evidence in registration files.

Who it applies to

Establishments in Mexico that manufacture, import, store or distribute medical devices, including each distributor added to a registration.

Applicable products

All devices covered by a registro sanitario.

General requirements

• Operating notice showing company name, address, authorized classification/manufacturing lines and COFEPRIS receipt number
• Sanitary responsible person with professional licence (cédula) meeting the applicable NOM, who also signs off technical information
• Legal representative established in Mexico

Typical documentation

• Copy of aviso de funcionamiento and aviso de responsable sanitario

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

File the notices with COFEPRIS before applying for registration.

Important notes

• Some activities may require a sanitary licence instead of a notice; check COFEPRIS rules for the specific establishment type.

Purpose

Kemenkes regulates medical devices through product marketing authorization (via the Regalkes system) and risk-based business licensing of producers and distributors (via OSS), including CPAKB/CDAKB good practice certification.

Who it applies to

Indonesian medical device producers and distributors (IDAK holders), who represent foreign manufacturers through a letter of authorization.

Applicable products

Medical devices and IVDs (and household health products, PKRT, under the same directorate).

Classification

Class A (low), B (low–medium), C (medium–high), D (high), ASEAN AMDD-aligned.

General requirements

• Izin edar (marketing authorization) for each device – AKD numbers for local, AKL for imported
• Producer licence/production certificate (local) or distributor licence (IDAK)
• Good distribution practice certificate (CDAKB) – announced as a prerequisite for izin edar from 2024
• Import/distribution reporting via Kemenkes e-report

Typical documentation

• See izin edar entry

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Obtain the business licence (producer or distributor) and CDAKB/CPAKB, then submit izin edar applications on regalkes.kemkes.go.id.

Important notes

• IDAK (distributor licence) replaced the older IPAK and SDAK names.
• Permenkes 62/2017 on izin edar is listed by Kemenkes as repealed; risk-based licensing now sits under PP 28/2025 and Permenkes 11/2025 (health subsector standards).

Purpose

Pre-market evaluation of safety, quality and performance before devices circulate in Indonesia.

Who it applies to

Local producers (AKD) and licensed distributors acting as sole agent/sole distributor for foreign manufacturers (AKL).

Applicable products

All classes A–D; evidence depth increases by class.

Classification

Classes A–D (the guideline cross-references I, IIa, IIb, III).

General requirements

• Valid production certificate (local products) or distributor licence (local and import distributors)
• Letter of authorization as sole agent/sole distributor from the principal, legalized by the Indonesian Embassy (imports)
• Certificate of Free Sale from the authority of origin
• Evidence of conformity with product standards and QMS (e.g. ISO 13485, ISO 9001, CE certificate)
• Technical forms (A–E) covering product description, specifications, design verification/validation, software validation (if any), labels and risk information

Typical documentation

• Regalkes forms A–E and supporting documents per class

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply online via Regalkes, pay PNBP fee; Kemenkes evaluates and issues an AKD/AKL number. Renewal may be applied for 9 months before expiry; late renewal is treated as a new application.

Validity and renewal

Per the 2017 guideline, validity follows the letter of authorization to the local sole agent/distributor, with a minimum of 2 years and maximum of 5 years.

Important notes

• Import and distribution reports must be submitted via Kemenkes e-report before renewal.
• The 2017 guideline gave target evaluation times by class; not reproduced as they may have changed.

Purpose

Ensures distributors of devices are licensed and follow Indonesian good distribution practice (Cara Distribusi Alat Kesehatan yang Baik).

Who it applies to

Companies importing or distributing medical devices in Indonesia.

Applicable products

All medical devices distributed in Indonesia.

General requirements

• Distributor licence (IDAK) via the OSS risk-based licensing system
• CDAKB certificate, announced by Kemenkes (Pengumuman 884/2024) as a requirement for izin edar
• CDAKB also needed for e-Katalog public procurement per Kemenkes

Typical documentation

• OSS licence application; CDAKB audit/certification via Kemenkes Seralkes system

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Obtain IDAK, then CDAKB certification through Seralkes (version 3 from 2025), before filing AKL applications.

Important notes

• Local manufacturers have a parallel production licence/certificate and good manufacturing practice (CPAKB) certification.

Purpose

The Medical Device Act and its amendment (No. 2, B.E. 2562/2019) with ministerial regulations and announcements govern manufacture, import, sale, classification, labelling and reporting of medical devices.

Who it applies to

Thai manufacturers and importers (foreign manufacturers act through a Thai importer), and in some cases sellers who need a sales licence.

Applicable products

Medical devices and IVDs; some products may be exempted from production/import/sale permission under Thai FDA rules.

Classification

Type (class) 1 low risk, Types 2–3 medium risk, Type 4 high risk, per the MoPH announcement on risk classification B.E. 2562 (2019).

General requirements

• Establishment registration for import (form ส.น.1) or manufacture (ส.ผ.1)
• Product authorization: listing (Class 1), detailed notification (Classes 2–3), licence (Class 4)
• Sales licence for certain device types
• GMP (manufacture) and GDP (import/sale) quality systems
• Electronic production/import/sale reporting and labelling per 2025 MoPH announcements

Typical documentation

• Establishment forms; product dossiers in Full or Abridged pathways (CSDT format for certain products)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Register the establishment, then submit product listing/notification/licence applications through Thai FDA e-submission.

Important notes

• Thai FDA's homepage announces that licences and notifications expire on 31 December 2569 (2026), with renewal open 1 October–31 December 2569 and late renewal (with daily fines) in January 2570 – check which authorizations this covers.

Purpose

Oversight of premises used to import, manufacture and store medical devices.

Who it applies to

Businesses that import or manufacture medical devices for sale in Thailand; an 'operator' named on the certificate is legally responsible.

Applicable products

All medical devices imported or manufactured for sale.

General requirements

• Registration certificate before product submissions
• Named operator (ผู้ดำเนินกิจการ) appointed by the company
• Controllers (ผู้ควบคุม) of production/import/sale where required
• GMP for manufacturers; GDP for import and sale establishments

Typical documentation

• Form ส.น.1 (import) or ส.ผ.1 (manufacture); change forms ส.น.3/ส.ผ.3, amendments ส.น.4/ส.ผ.4; forms updated from 1 May 2569 (2026)

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

Apply to the Medical Device Control Division; renew or cancel via the separate renewal/cancellation forms.

Purpose

Product-level authorization before sale in Thailand.

Who it applies to

Registered Thai manufacturers or importers.

Applicable products

All classes; 16 listed product categories (e.g. HIV and methamphetamine test kits) must use a Full CSDT application.

Classification

Class 1 (and animal devices): listing; Classes 2–3: detailed notification; Class 4: licence (ministerial regulations B.E. 2563).

General requirements

• Hold establishment registration
• Classify per MoPH risk-classification announcement B.E. 2562 and group per FDA grouping criteria B.E. 2561
• Submit via Full or Abridged pathway as applicable

Typical documentation

• Product dossier (CSDT-based for notification/licence); Thai FDA lists required documents by pathway

A general list; what is actually required depends on the device, its class and the manufacturer’s role.

Assessment process

File on the Thai FDA e-submission system; obtain a listing certificate, notification receipt or licence.

Important notes

• Third-party sources describe an auto-approval option for qualifying Class 1 devices from 2025 – not confirmed on Thai FDA pages reviewed.