Skip to content

Explore the Global Medical & Surgical Industry

info@surgifacts.com
Get Listed

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

Filters

Clear all
Country or region
Requirement type
Device category
Applicability

3 entries

Switzerland

SwitzerlandImporter or Distributor RequirementsLabeling and TraceabilityPost-Market Surveillance

Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO) (MedDO / IvDO)

Swissmedic (Swiss Agency for Therapeutic Products); Federal Office of Public Health (FOPH) for legislation

Swiss device rules mirror EU MDR/IVDR; Switzerland unilaterally recognises EU conformity assessment (CE marking), but foreign makers need a Swiss authorised representative.

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.

Points still being verified

  • The EU-Switzerland MRA chapter on medical devices has not been updated, so Switzerland is treated as a third country by the EU and relies on unilateral measures; a 2022 parliamentary motion on accepting devices approved under non-European regimes (e.g. FDA) was under examination - status not confirmed.
Official sources (3)

Last verified 29 October 2026

SwitzerlandImporter or Distributor RequirementsProduct Registration or Listing

Swiss authorised representative (CH-REP) and importer obligations

Swissmedic

Manufacturers outside Switzerland must appoint a Swiss authorised representative; CH-REPs and importers register in swissdamed and receive a CHRN.

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.
Official sources (2)

Last verified 29 October 2026

SwitzerlandProduct Registration or Listing

Device registration in swissdamed (Art. 108 MedDO)

Swissmedic

Since 1 July 2026, devices and system/procedure packs placed on the Swiss market must be registered in swissdamed; transition runs to 31 Dec 2026.

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.

Points still being verified

  • Transition ends 31 December 2026 - update the entry after that date.
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.

For manufacturers

Manufacturer or supplier with documented certifications?

Request a company listing. Certifications and regulatory claims appear on a profile only after we have confirmed them against an official source. Every submission is reviewed before anything is published.

Request a company listing

How listings work · A listing is not an endorsement.