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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

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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

South Africa

South AfricaManufacturer or Establishment LicensingPost-Market SurveillanceProduct Registration or Listing

South Africa Medical Device Regulation – Medicines and Related Substances Act and Medical Device/IVD Regulations (2016) (SAHPRA)

South African Health Products Regulatory Authority (SAHPRA)

South Africa currently regulates devices mainly through SAHPRA establishment licences; product registration is planned but not yet called up.

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.

Points still being verified

  • Product registration is 'still in development' per SAHPRA; requirements may change once the call-up plan is published.
Official sources (2)

Last verified 29 October 2026

South AfricaImporter or Distributor RequirementsManufacturer or Establishment LicensingQuality Management Standards

Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs (Establishment Licence)

SAHPRA

SAHPRA licence needed by manufacturers, distributors and wholesalers of Class B–D devices and of sterile or measuring Class A devices.

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.

Points still being verified

  • Licence validity period: a search excerpt of an older guideline mentioned five years, but this was not confirmed in the current guideline – left blank.
  • Fees not reproduced.
Official sources (4)

Last verified 29 October 2026

South AfricaRisk Management Standards

SAHPRA Classification of Medical Devices and IVDs (SAHPGL-MD-04)

SAHPRA

South Africa classes devices A–D; SAHPRA names scissors, artery forceps, tissue forceps, clamps, osteotomes and chisels as Class A reusable surgical instruments.

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.
Official sources (1)

Last verified 29 October 2026

South AfricaProduct Registration or Listing

Medical Device Product Registration in South Africa (Call-Up Pending)

SAHPRA

SAHPRA says device registration is still in development; a call-up plan will phase devices in by type and class, with reliance on recognised regulators.

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.

Points still being verified

  • Status may change at short notice when SAHPRA publishes its call-up plan.
Official sources (1)

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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