EU Authorized Representative for South Africa: Establishment Licence to CE Marking

South Africa licenses the establishment. Nobody has assessed your device.

The distinction that governs every South African export project is the one between a licence and a conformity assessment, and SAHPRA states its side of it plainly: "No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA medical device establishment licence." (SAHPRA, Medical Devices) The licence comes in three categories — manufacturer, distributor and wholesaler — under the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) and the Regulations relating to Medical Devices and IVDs published in Government Gazette No. 40480 on 9 December 2016.

A licence answers the question of who may trade. It does not answer whether any particular device is safe and performs as claimed. As part of the application a company lists the devices it manufactures, distributes or wholesales, and declares the status of its quality management system — a list and a declaration, not an assessment. Manufacturers, distributors and wholesalers of non-sterile, non-measuring Class A devices are exempt from licensing altogether under SAHPRA position statement 9.106. If your entire European assumption rests on holding a licence, you are holding the wrong instrument.

The representative SAHPRA asks for is a natural person in South Africa

This is worth stating carefully, because the shared vocabulary causes real confusion. SAHPRA requires that establishments applying for a licence "must appoint an Authorised Representative who must be a natural person based in South Africa" (SAHPRA, Medical Devices), responsible for adherence to the law, regulations and guidelines. That is a named individual attached to a licensed establishment, closer in function to a responsible pharmacist than to anything in MDR.

The MDR role is a different creature entirely. It is a legal or natural person established within the Union, holding a written mandate from a manufacturer located outside it, performing the tasks listed in Article 11(3) — and exposed under Article 11(5) to legal liability for defective devices jointly and severally with the manufacturer. Your South African representative cannot fill it, and appointing one has no bearing on the other. They are two unrelated obligations that happen to share a phrase.

A registration system still being written, and a call-up that has not reached you

SAHPRA is explicit that the registration process for medical devices remains in development, with a Registration Call-Up Plan to be published setting out the phased approach by which device types and classes will be prioritised and called up sequentially. The Authority also intends to operate reliance pathways, verifying registration in recognised jurisdictions including Australia, the United States, the European Union, Brazil, Canada and Japan, or WHO prequalification for IVDs.

Two things follow. First, most South African manufacturers have never taken a device through a pre-market review anywhere, because their own system has not yet required one — so the discipline of assembling a dossier for an assessor rather than an inspector is genuinely new. Second, the reliance runs inward. A CE marking will help a device into South Africa. Nothing about a South African instrument helps a device into the Union, and there is no agreement between the two that would change that.

The ISO 13485 phase-in is the piece that genuinely travels

Here is the good news, and it is substantial. SAHPRA has made certification to ISO 13485:2016 a standing requirement for licence holders under section 22C, phased in over several years: licence renewals from 1 June 2025 require a valid certificate from a SAHPRA-recognised conformity assessment body, with later phases covering existing certificate holders, licence amendments and product list notifications, and finally all new licence applications from 1 April 2028. The requirement applies even where the licence holder is otherwise exempt from licensing.

That means a South African manufacturer arriving at MDR in the next few years will already hold a certified quality management system built to the standard MDR expects. Design control, CAPA, supplier evaluation, management review and post-market feedback loops will exist and will already have survived external audit. It shortens the European project more than anything else on this page — but it is a head start, not a pass. Under MDR Annex IX, Chapter I, the manufacturer lodges an application with a notified body and that body performs its own assessment. A certificate from an accredited CAB is not a certificate from a body designated under Article 42.

Affiliate member, not member: where South Africa sits at the MDSAP table

South Africa participates in the Medical Device Single Audit Program as an Affiliate Member. The five Members whose regulatory decisions the programme was built to serve are Australia’s TGA, Brazil’s ANVISA, Health Canada, Japan’s MHLW and PMDA, and the US FDA. The European Union sits as an Official Observer.

It is worth being precise about what that means for a South African file. Affiliate status is a route to alignment and information, not an acceptance mechanism, and the Union’s observer status means MDSAP reports have no formal standing in a European conformity assessment even for the five Members. So a South African manufacturer gains nothing transferable from MDSAP on the EU side — but if the United States or Canada is also on the roadmap, the audit economics are worth modelling before you commission separate programmes.

From a licence file to a conformity file

What has to be built, beyond the quality system you will already have: technical documentation to Annexes II and III, with a general safety and performance requirements checklist worked clause by clause against Annex I; a classification derived from the twenty-two rules in Annex VIII and justified in writing; a clinical evaluation under Article 61 and Annex XIV; a post-market surveillance plan to Annex III; and UDI assignment. Then the Union-facing steps: the Article 11 mandate accepted in writing, actor registration and the single registration number that the manufacturer must use when applying to a notified body, and the representative’s name and registered place of business on the label under Annex I, Section 23.2(d).

One structural point South African exporters underestimate: MDR ties the information supplied with a device to the official language or languages of each Member State where it is made available (Art. 10(11)). An English-only pack that satisfies SAHPRA covers Ireland and Malta. It does not cover the rest. Medex holds EUDAMED authorised representative SRN TR-AR-000057550, with an in-house PRRC and a deputy, and runs the mandate and the EUDAMED registrations together.

Before the first European order: what SAHPRA licence holders ask

We hold a manufacturer establishment licence. Is that recognised in Europe?

No, and it is not the kind of document Europe recognises. MDR has no licensing of economic operators at all: the Regulation controls devices through conformity assessment and controls operators through duties in Articles 10 to 14 and registration in EUDAMED. Your licence proves you may trade in South Africa and nothing more.

Our Class B device — what is it in Europe?

Re-derive it. South Africa uses the A to D scheme; MDR uses I, IIa, IIb and III on twenty-two rules in Annex VIII. There is no lookup table, and the classification has to be argued in your technical documentation because the notified body will examine the argument. Class B products commonly land in MDR class IIa, but that is a tendency, not a rule.

We are a distributor, not a manufacturer. Do we need a representative?

Only if you sell into the Union under your own name, in which case you have become the manufacturer under Article 16(1)(a) and you do. If you distribute another company’s branded device, that manufacturer appoints the representative, and your own duties in Europe would be those of an importer or distributor under Articles 13 and 14 — neither of which a South African entity can hold, since both require presence in the Union.

Will the SAHPRA registration call-up affect our EU timeline?

Not directly, but the overlap is worth planning. Much of what a call-up will eventually demand — a structured dossier, a classification rationale, evidence of performance — is the same material MDR Annex II requires now. Building it once, to the higher European standard, is cheaper than building it twice.