Legislative History: From the MCC to SAHPRA under Act 101 of 1965

1. Key takeaways

The legal foundation of South African medical device regulation is the Medicines and Related Substances Act, Act No. 101 of 1965, with device regulation resting on the enabling power in Section 35(1)(xxvii) of that Act. The supporting Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) were published on 9 December 2016 under Government Gazette No. 40480, Notice No. 1515, containing 29 regulations. Regulatory authority transitioned from the Medicines Control Council (MCC) to the South African Health Products Regulatory Authority (SAHPRA), which has been operational since 2018. When reading any South African document, companies should first determine which of the four layers it belongs to — Act, Regulations, guideline (SAHPGL) or Communication — because the layer determines its legal force. Misreading this hierarchy is one of the most frequent and avoidable errors in South African regulatory work: a guideline is treated as binding law, or a draft is treated as current, simply because the reader did not check which layer the document occupies. A layered reading habit protects both compliance planning and external claims.

2. Legal basis

3. Expert insights

Insight one: a 1965 medicines Act governs devices, and this is the underlying feature of the South African system. Unlike Macao, the European Union and the Chinese mainland, each of which has a dedicated device law, South Africa places devices inside a medicines Act framework. This has two direct consequences. First, device provisions naturally carry the administrative character of medicines regulation: the language of licensing, registration, inspection and penalties mirrors the medicines regime. Second, device rulemaking must rely on delegated legislation under Section 35(1)(xxvii), so the core rules sit not in the Act itself but in Notice 1515, the supporting regulations. Companies that understand this structure know where to look when a question of legal force arises.

Insight two: the 29 regulations of Notice 1515 cover the full lifecycle. Its arrangement of regulations already includes: definitions (1), international tenders (2), import (3), goods in transit (4), licences (5), licence validity and renewal (6), appeals (7), registration applications (8), register information (9), amendments to the register (10), classification (11), registration certificates (12), components (13), destruction (14), sampling (15), clinical trials and clinical investigations (16), adverse event reporting and vigilance (17), investigations (18), offences and penalties (19), compliance requirements (20), advertising (21), labelling (22), instructions for non-IVDs (23), instructions for IVDs (24), custom-made devices (25), implant records (26), transitional arrangements for unlicensed establishments (27), transitional arrangements for unregistered devices (28) and the short title (29). The institutional skeleton was completed in 2016, which is why later developments have been administrative rather than legislative.

Insight three: the 2017 licensing call-up notice was the first mandatory line to take real effect. The notice published on 24 February 2017 required manufacturers and distributors to lodge licence applications within 6 months and wholesalers within 12 months. This line converted establishment licensing from paper to practice and remains the actual starting point of every market access obligation in South Africa today. Any timeline analysis of South African compliance obligations should therefore begin with this notice rather than with the 2016 regulations themselves.

Insight four: the 2021 draft signals a framework rebuild but is not yet in force. The draft published on 21 May 2021 contains 28 regulations, reorganised into chapters covering supply, registration, licensing, administration, and investigations and penalties. It proposes replacing the term Council with Authority throughout, and adds refined provisions on custom-made devices and Class D records. The draft is currently undergoing review by independent experts and has not replaced the 2016 regulations; companies should continue to apply Notice 1515 for all submissions until an effective date is formally published.

Insight five: SAHPRA documents fall into four layers, decreasing in legal force but increasing in practical detail. The Act and Regulations are the binding layer; the SAHPGL guideline series (for example SAHPGL-MD-04 on classification and SAHPGL-MD-03 on vigilance) forms SAHPRA’s official interpretation layer; Communications to Industry (such as MD01-2025/2026) are the immediate policy layer, frequently used to set transition milestones; and GLF forms (such as GLF-MD-06A) are the operational layer. Whether a requirement is mandatory is judged first by identifying which layer it occupies, and this is the foundational method of South African regulatory analysis.

4. Practical recommendations

1. Apply Notice 1515 as the current submission basis: the 2021 draft has no present legal effect.
2. Maintain a layered register of SAHPRA documents: manage Act, Regulations, guidelines and Communications separately, with update dates.
3. Subscribe to Communications to Industry: transition milestones are almost always set by these communications.
4. Check references to the Council in the regulations: the current text still refers to the MCC, which corresponds in practice to SAHPRA.
5. Prepare a gap analysis against the 2021 draft: the restructured chapters may change dossier and licence categorisation.

5. Verification checklist

• □ Verify that Act No. 101 of 1965 is the parent statute for device regulation in South Africa
• □ Verify that Notice No. 1515 (2016-12-09) is the current supporting regulation, comprising 29 regulations
• □ Verify that the 2021 GN 435 is a draft and not yet in force
• □ Verify that the notice of 2017-02-24 is the actual mandatory starting point for establishment licensing
• □ Verify that the difference in force between SAHPGL guidelines and MD-numbered Communications is documented
• □ Verify that a version register of SAHPRA documents is maintained (document number, version and update date)
• □ Verify that references to the Council in applicable provisions point to SAHPRA in practice
• □ Verify that regulatory amendment progress is on the monitoring list

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.