South Africa Medical Device Registration Basics: The Two-Track System

1. Key takeaways

Medical device regulation in South Africa operates as a two-track structure that is advancing at different speeds. Track one, establishment licensing, is already mandatory: any entity that manufactures, imports, exports, distributes or wholesales medical devices in South Africa must hold a SAHPRA Medical Device Establishment Licence (MDEL) under Section 22C(1)(b) of the Medicines and Related Substances Act, and may not manufacture, distribute, import, export or sell devices without a valid licence. Track two, product registration, has not yet started: under Section 14 of the same Act, the sale of unregistered devices is only prohibited once SAHPRA has issued a Call-Up Notice for a specific device or device category. As of 29 October 2026, SAHPRA has not issued any product registration call-up notice, which means that no SAHPRA product registration number currently exists in the South African market. This determines the priority of corporate action: secure the establishment licence first, and prepare the registration dossier in parallel. Companies that treat these two tracks as a single obligation risk both over-claiming in their marketing and under-preparing for the registration regime that SAHPRA is visibly building. The two tracks bind different subjects, follow different legal provisions, and mature on different timelines, so they must be planned and budgeted as separate workstreams.

2. Legal basis

3. Expert insights

Insight one: Section 14 creates a conditional prohibition, not an absolute one. The provision is structured as a condition: if SAHPRA has issued a declaration requiring registration, then the device may not be sold unregistered. This means that being unregistered is not, by itself, unlawful in South Africa today; what is unlawful is operating an establishment without a licence. The most common misconception GRZAN corrects when advising manufacturers is the assumption that South Africa is a market where a product registration certificate must be obtained first. In reality, the only mandatory market access document at present is the establishment licence, and every compliance plan should start from that fact rather than from habits imported from other jurisdictions.

Insight two: Regulation 11(2) hard-wires the call-up notice as a statutory mechanism. The provision states that medical devices and IVDs, other than custom-made devices, must be registered with the Authority under call-up notices before they may be sold or used in South Africa. This single sentence matters enormously, because it shows that the legal pathway for product registration has existed since 2016; what is missing is only an administrative act by SAHPRA. Companies should treat the question of when a call-up notice will appear as a monitorable regulatory event with defined sources, not as an unconfirmed rumour circulating at trade fairs.

Insight three: the timing gap between the two obligations creates a compliance illusion. Many companies believe that once they hold an establishment licence their obligations are complete. SAHPRA has made clear that the registration process is still under development and that a Registration Call-Up Plan will announce the device types and classes to be called up in phases. Companies that prepare their dossiers before the announcement and companies that start only after it will face entirely different levels of time pressure. This preparation window is precisely where the most valuable compliance investment lies right now, because dossier components such as classification, GMDN coding and essential principles arguments can all be completed in advance.

Insight four: establishment licensing and product registration are not two sequential steps but two layers binding different subjects. The establishment licence binds the enterprise (manufacturers, distributors, wholesalers); product registration binds the product. A company can hold an establishment licence while none of its products carries a registration number; conversely, once a product is called up for registration, a valid establishment licence will be a precondition. Indeed, one of the eligibility conditions for the registration feasibility study is precisely holding an establishment licence whose scope of activities includes import or manufacture, a design feature that directly confirms the two-layer structure of the South African regime.

Insight five: the regulatory centre of gravity is migrating from regulating establishments to regulating products. SAHPRA has issued a suite of lifecycle-facing documents, including the Medical Devices Reliance Guideline (SAHPGL-MD-22, dated 25 February 2026), the guideline on post-market surveillance and post-market clinical follow-up studies (SAHPGL-MD-18, dated 9 September 2025), and the registration feasibility study report (dated 31 March 2026). The document architecture is taking shape ahead of any call-up notice, and this is the most reliable signal for judging how close the first registration call-up is. Firms that read this signal correctly can sequence their preparations months ahead of competitors.

4. Practical recommendations

1. First determine whether an establishment licence is required: check each activity scope (manufacture, import, export, distribution, wholesale) one by one.
2. Screen for the Class A exemption at the same time: non-sterile, non-measuring Class A devices may be exempt from licensing (Position Statement 9.106).
3. Set the call-up notice as a monitored event: subscribe to SAHPRA communications and the Government Gazette and assign an owner.
4. Start dossier preparation before any announcement: classification decisions, GMDN codes and essential principles arguments can be completed in advance.
5. Never claim to hold a South African registration certificate: as of the verification date no such product registration number exists, and such claims are misleading.

5. Verification checklist

• □ Verify the company’s scope of activities in South Africa and the corresponding licence type
• □ Verify whether the Class A device licensing exemption applies (Position Statement 9.106)
• □ Verify that, as of the verification date, SAHPRA has issued no product registration call-up notice
• □ Verify that publication of the Registration Call-Up Plan is on the regulatory monitoring list
• □ Verify that the establishment licence is the common precondition for the feasibility study and any future registration
• □ Verify that an initial risk classification of the product has been completed as Class A, B, C or D
• □ Verify that external messaging never uses the phrase South African registration certificate
• □ Verify that a South African Authorised Representative (AR) candidate has been identified (must be a natural person resident in South Africa)

Regulatory information verified as of 29 October 2026. The instruments, guidelines and effective dates described in this article are limited to the content published by the official sources listed under the legal basis above as at that date; where official documents are updated, the latest published version prevails.

• South Africa local support: GRZAN assists manufacturers in the Chinese mainland and abroad with SAHPRA Medical Device Establishment Licence (MDEL) applications and product registration preparation, including Authorised Representative (AR) arrangements, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification decisions, technical documentation, and the setup of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway arguments, technical documentation and essential principles conformity arguments, labelling and instructions for use localisation in English, and post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.