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Medical Device Certifications & Regulatory Requirements

What the main standards, conformity marks, approvals, registrations and licences mean, and which apply in 20 markets. Search an entry or browse by category below.

Marks, standards and authorities at a glance

Badges are text labels made by SurgiFacts for navigation. They are not official logos or marks and do not imply endorsement, certification or approval by any body.

Quality management & ISO standards

Standards for how a company runs its quality system and manages risk. A QMS certificate covers the organisation, not a product, and is not a market authorization.

Product safety & technical standards

Technical standards describe how to design, test or validate a device. Meeting one is evidence toward legal requirements; it is not itself an approval or a certificate to sell.

International regulatory authorities

Regulators grant the legal permission to supply a device. Depending on the market and risk class that is a clearance or approval, a registration or listing, and often a licence for the company itself.

Regional conformity frameworks

Conformity assessment shows a device meets the rules. A conformity marking is affixed by the manufacturer after that assessment; it is not a certificate issued to the product by a regulator.

Country and regional requirements

The framework and main requirements for each market, after the international standards. Open an entry for scope, typical documentation, process and official sources. Related: Surgical instrument manufacturers · Medical AI companies

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4 entries

Australia

AustraliaImporter or Distributor RequirementsLabeling and TraceabilityPost-Market Surveillance

Australian medical device regulation (Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002) (TGA)

Therapeutic Goods Administration (TGA), Australian Government

Devices must be in the ARTG before supply in Australia, via an Australian sponsor, after meeting the Essential Principles and a conformity assessment procedure.

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.

Points still being verified

  • TGA's 2026 consultation on conformity assessment procedures proposed aligning the classification/assessment of Class I reusable surgical instruments with the EU (reuse aspects assessed by a third party). Consultation closed 14 April 2026; outcome not yet published at research date. Rules for reusable instruments may change.
Official sources (4)

Last verified 29 October 2026

AustraliaProduct Registration or ListingRegulatory Approval

Inclusion in the Australian Register of Therapeutic Goods (ARTG)

Therapeutic Goods Administration (TGA), Australian Government

Unless exempt, a medical device must be included in the ARTG by its Australian sponsor before it can be imported, supplied or exported.

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.

Points still being verified

  • Annual charges and fee amounts not verified - do not quote figures.
Official sources (3)

Last verified 29 October 2026

AustraliaImporter or Distributor RequirementsPost-Market Surveillance

TGA sponsor obligations for medical devices

Therapeutic Goods Administration (TGA), Australian Government

The sponsor is the Australian legal entity responsible for a device's ARTG entry, substantiating compliance and reporting adverse events and recalls.

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.
Official sources (2)

Last verified 29 October 2026

AustraliaQuality Management StandardsRegulatory Approval

Conformity assessment evidence: TGA certificates and comparable overseas regulator evidence (TGA CA / COR)

Therapeutic Goods Administration (TGA), Australian Government

Manufacturers show conformity through TGA conformity assessment certificates or accepted overseas evidence, e.g. EU notified body, FDA, Health Canada, MDSAP.

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.

Points still being verified

  • Which device types still require mandatory TGA certification conflicts between TGA pages (2021 change vs current IVD guidance) - verify per device type.
  • TGA's 2026 consultation on conformity assessment procedures proposed aligning the classification/assessment of Class I reusable surgical instruments with the EU (reuse aspects assessed by a third party). Consultation closed 14 April 2026; outcome not yet published at research date. Rules for reusable instruments may change.
Official sources (3)

Last verified 29 October 2026

Understanding certifications

These terms are not interchangeable. A quality-system certificate, a product authorization, a registration and an establishment licence are different things, granted by different bodies for different purposes. Which ones apply depends on the product, its intended use, its risk class, the company’s activities and the target market.

Product certification

Product certification is a third-party attestation that a specific product meets stated requirements; it is not the same as permission to sell a medical device.

Explains what a product certificate or certification mark means: an independent body has evaluated a product (or product type) against defined requirements, such as a safety standard, and attests that it conforms.

  • A product certificate does not by itself authorize sale of a medical device in a regulated market; regulators have their own authorization routes.
  • Product certification is different from QMS certification (e.g. ISO 13485), which covers the organization's management system, not a specific product.
  • Check that a certificate names the exact model, the standard edition, and the issuing body; certificates cannot be transferred to look-alike products.
  • Example: CE marking of a medical device is a manufacturer's declaration of conformity with EU law, sometimes involving a notified body; it is not a voluntary private certification mark.

Regulatory approval / marketing authorization

Marketing authorization is a regulator's (or legally designated body's) decision allowing a device to be placed on a market; routes and names differ by country.

Explains the legal step that permits a medical device to be sold in a given jurisdiction, and why different terms (clearance, approval, certificate, licence, registration) are not interchangeable.

  • FDA 510(k) clearance, De Novo grant and PMA approval are different outcomes; calling a cleared device 'FDA approved' is inaccurate.
  • FDA establishment registration and device listing are not FDA approval of the establishment or its devices.
  • An establishment licence (permission to operate a business activity) is different from authorization to market a specific device.
  • Authorization in one country does not carry over to another, although some regulators use reliance or abridged routes.

Product registration and listing

Registration and listing put a company or device on a regulator's record; in many systems this is administrative and does not mean the device was reviewed or approved.

Explains that many regulators keep databases of establishments and devices, and that the meaning of 'registration' varies widely: in some countries it is a filing, in others it is the actual marketing authorization.

  • US: FDA establishment registration and device listing are required for many firms, but FDA states that registration does not denote approval of the establishment or its devices.
  • EU: actor and device registration in EUDAMED is a separate obligation from conformity assessment and CE marking.
  • In some countries 'registration' is the name of the marketing authorization itself, so always read what the specific regulator means.
  • A registration number alone is not evidence of quality, safety or performance.

Manufacturer / establishment licensing

An establishment licence permits a company to carry out activities such as manufacturing, importing or distributing devices; it does not authorize any specific device.

Separates permission for a business to operate (a site or activity licence) from permission to market a particular device.

  • Holding an establishment or manufacturing licence does not mean every product the company makes is authorized for sale.
  • Conversely, a device authorization usually does not license an unrelated importer or distributor to handle it.
  • Names differ: licence, permit, registration, manufacturing licence, import licence.

Quality management system (QMS) certification

QMS certification confirms an organization's management system meets a standard such as ISO 13485; it does not certify or authorize any individual product.

Explains what an ISO 13485 or ISO 9001 certificate means: an independent certification body audited the organization's QMS against the standard for a stated scope and sites.

  • ISO itself does not certify organizations; certification bodies do.
  • ISO 13485 is a QMS standard; an ISO 13485 certificate is not a product approval, CE marking or FDA clearance.
  • Some regulators require or rely on QMS certification (e.g. Health Canada requires an MDSAP-issued ISO 13485 certificate for Class II-IV licence applications), which is a regulatory use of a voluntary standard.
  • Check that the certification body is accredited for that scope and that the certificate can be verified with the issuer.
  • QMS certification is different from FDA inspection: FDA does not issue ISO 13485 certificates.

Conformity assessment

Conformity assessment is any process showing that specified requirements are met: testing, inspection, certification, or a manufacturer's own declaration.

Gives the umbrella term for how products, processes, systems or organizations are shown to meet requirements, and explains its legal meaning in the EU medical device framework.

  • CE marking signals that the manufacturer claims conformity with all applicable EU requirements following the required conformity assessment; it is not a quality mark or a product certification by the EU.
  • A notified body certificate under the MDR is part of conformity assessment, not an EU 'approval' issued by the European Commission.
  • Using a harmonised standard gives a presumption of conformity only for the requirements that standard covers.

Accreditation of certification, inspection and testing bodies

Accreditation is a formal check of a certification body or laboratory's competence; it is not a certification of the device maker.

Explains the layer above certification: accreditation bodies assess whether certification bodies, labs and inspection bodies are competent and impartial.

  • Manufacturers are certified, not accredited; a company claiming to be 'ISO 13485 accredited' is usually misusing the term.
  • Regulatory designation is separate from accreditation: EU notified bodies are designated by member-state authorities under the MDR/IVDR, and MDSAP auditing organizations are recognized by the participating regulators.
  • FDA's ASCA programme uses accredited testing laboratories for certain recognized standards; it is a voluntary FDA programme in which testing laboratories accredited to ISO/IEC 17025 plus ASCA specifications perform testing for premarket submissions; it does not replace premarket review.
  • Unaccredited certificates may not be accepted by buyers or regulators.

Product safety and performance standards

Safety and performance standards define technical methods and requirements for products; they are voluntary unless a law or regulator makes them mandatory or recognises them.

Explains how technical standards (e.g. IEC 60601 series, ISO 10993 series, ISO 11135/11137) relate to regulation: they are tools to show requirements are met, not laws themselves.

  • In the EU, applying harmonised standards is voluntary but gives a presumption of conformity with the requirements they cover.
  • FDA recognition can be complete or partial; a declaration of conformity to a recognized standard can support, but does not replace, a premarket submission.
  • Standards have editions and transition periods; an outdated edition may no longer be accepted.
  • Not every standard applies to every device: e.g. IEC 60601-1 applies to medical electrical equipment, not to a manual stainless-steel forceps.

Market-specific labelling and documentation

Each market sets its own rules for labels, instructions for use, languages, identifiers and local contact details; international standards help but do not override them.

Explains why the same device may need different labels and documents in different markets, and how labelling standards fit in.

  • ISO 15223-1 symbols and ISO 20417 content requirements are voluntary standards; the law of each market decides what is mandatory.
  • EU MDR Annex I Chapter III sets EU labelling and IFU requirements; FDA labelling rules are in 21 CFR (e.g. Part 801).
  • A symbol accepted in one market may need accompanying text in another.

Medical device classification

Every market classifies devices by risk, but the systems differ: US Class I/II/III, EU Class I/IIa/IIb/III and India’s Class A–D are not equivalent. Classification follows the intended purpose and each jurisdiction’s rules, not the manufacturer’s product description alone.

Risk-based device classification

Devices are grouped into risk classes that drive the authorization route; each country has its own rules and the class systems are not interchangeable.

Explains that regulators sort devices from lower to higher risk, and that the class determines how much evidence and third-party involvement is needed.

  • US uses Class I, II, III; the EU MDR uses Class I, IIa, IIb, III (with sub-categories such as sterile, measuring and reusable surgical instruments in Class I); India's Medical Devices Rules 2017 use Classes A, B, C, D. These do not map one-to-one.
  • Classification depends on intended purpose, duration of contact, invasiveness, body site, energy source and other factors defined in each jurisdiction's rules.
  • A manufacturer's marketing description or a supplier's catalogue label does not decide the class; the applicable rules applied to the intended purpose do.
  • The same instrument can fall into different classes in different markets, and a change in intended use can change the class.
  • IVD classification is separate in many systems (e.g. EU IVDR Classes A-D).

Related FAQs

All certification and regulatory FAQs

This directory is provided for general informational and educational purposes only. Medical device regulatory requirements vary according to product classification, intended use, manufacturer or importer activities, and destination market. Requirements may change over time. This information is not legal or regulatory advice and does not guarantee market authorization. Manufacturers should verify the applicable requirements with the relevant regulatory authority and qualified regulatory professionals.

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