Section 14 and the Call-Up Notice: Conditional Registration Regime

1. Key takeaways

The mandatory force of product registration in South Africa derives from Section 14 of the Medicines and Related Substances Act: the section prohibits the sale of medical devices that are not yet registered, but it applies only where SAHPRA has issued a declaration requiring registration for that device or its class — that is, a Call-Up Notice. The supporting regulation, Regulation 11(2) of Notice 1515, likewise provides that devices must be registered under a call-up notice before they may be sold or used. As of 29 October 2026, SAHPRA has issued no product registration call-up notice, and the SAHPRA website states expressly 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. The conclusion is that no SAHPRA product registration number exists today in South Africa. Companies entering the market must therefore anchor their compliance in the establishment licence regime, while monitoring the call-up pipeline closely, because the legislative socket for registration has been in place since 2016 and the switch can be thrown by administrative decision alone.

2. Legal basis

3. Expert insights

Insight one: Section 14 is a switch, and the switch has not yet been pressed. The provision is conditional — first the call-up notice, then the prohibition. This is entirely different from absolute formulations such as Macao’s rule that devices not completing registration by 2026-07-01 may not circulate, or the European Union’s rule that products without CE marking may not be placed on the market. Misreading this point produces two opposite errors: abandoning the South African market because the product is assumed to need a registration number first, or doing no preparation at all on the assumption that registration will never arrive. Both errors are avoidable by reading the statute as written.

Insight two: Regulation 11(2) and Section 14 corroborate each other, proving the channel is reserved. Both instruments use the wording call up notices. This demonstrates that the legislature reserved the legal interface for phased call-ups as early as 2016; the question is not one of amending the law but of an administrative decision — in principle, SAHPRA can issue a notice at any time, which is the source of the timing uncertainty companies must manage.

Insight three: the feasibility study is an announcement before the announcement. The voluntary registration feasibility study launched in May 2024 focused Phase 1 on HIV and TB related IVDs and non-IVDs, targeting 32 products with approximately 22 actually received; the study report was published on 31 March 2026; Phase 2 (2026) turns to oncology (breast, prostate and lung cancer), dominated by Class C and Class D devices, and the study is expected to run to the end of 2027. The feasibility study does not generate registration numbers, but it is the most direct signal of which product categories will be called up first — the first call-up will very likely cover the categories studied, so portfolio overlap with those categories should drive dossier priorities now.

Insight four: the reliance pathway was designed before the call-up lands. The Medical Devices Reliance Guideline (SAHPGL-MD-22 v1, dated 25 February 2026) already establishes reliance principles across licensing, registration, clinical trials, ISO 13485 audits, and post-market and market surveillance, and expressly recognises approvals from the FDA, the European Union, Australia’s TGA, Japan’s PMDA, Canada’s Health Canada and Brazil’s ANVISA, as well as WHO prequalification for IVDs. The regulator has fixed its review methods before starting the call-up, and this ordering shows that the technical preparation for the first call-up is essentially complete.

Insight five: no registration number does not mean no compliance obligations. Establishment licensing, ISO 13485, vigilance reporting, annual retention fees, ASOCI annual compliance information, and labelling and instructions requirements are all already in force. A company whose products carry no registration number still bears the complete set of post-market obligations. Waiting for the registration system to land before acting is the most dangerous strategy available today, because every obligation that exists now is enforceable now, and enforcement history shows SAHPRA inspects operating establishments regardless of registration status.

4. Practical recommendations

1. Treat the call-up notice as a tier-one monitoring event: track the Government Gazette and SAHPRA communications.
2. Prioritise by feasibility study coverage: HIV and TB, and oncology-related Class C and Class D products, are most likely to be called up first.
3. Complete the dossier skeleton before any announcement: classification, GMDN, essential principles and technical documentation first.
4. Perform the obligations already in force in parallel: licensing, ISO 13485, vigilance and annual retention fees are not excused by the absence of a registration number.
5. Gate external claims strictly: never claim to hold a South African registration certificate.
6. Evaluate participation in the feasibility study: it is the only lawful channel for stress-testing a dossier before the call-up.

5. Verification checklist

• □ Verify that Section 14 is a conditional prohibition, contingent on a published call-up notice
• □ Verify the call up notices mechanism in Regulation 11(2)
• □ Verify that, as of the verification date, SAHPRA has issued no product registration call-up notice
• □ Verify that the Government Gazette and SAHPRA communications are subscribed for call-up monitoring
• □ Verify that call-up priorities have been pre-assessed by feasibility study coverage
• □ Verify that all obligations in force apply despite the absence of a registration number
• □ Verify that external messaging is unified and never uses the phrase South African registration certificate
• □ Verify that participation in the feasibility study has been assessed (an establishment licence is required first)

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.