The 2021 Draft Medical Device Regulations GN 435 Explained

1. Key takeaways

South Africa’s current device regulations are Notice 1515 (29 regulations in total), published on 9 December 2016. The national Department of Health published Government Notice No. 435 (GN 435) in the Government Gazette No. 44593 on 21 May 2021, opening public comment on a draft of new Medical Device Regulations containing 28 regulations. The draft has not yet entered into force and is currently undergoing review by independent experts; companies must still apply the 2016 Regulations in their submissions, but they should treat the draft as a forward-looking reference for how the framework is evolving. Reading the two instruments side by side reveals where the regulator’s attention is moving — from market access towards the full circulation and use lifecycle — and allows compliance systems to be built once, in a shape that will survive the transition rather than need rebuilding when the new text finally arrives.

2. Legal basis

3. Expert insights

Insight one: the chapter structure of the draft is clearer than that of the current regulations. The 2021 draft organises the provisions into Supply, Registration, Licensing, Management, and Investigations, Offences and Penalties. Supply and Management are topics that do not stand as separate chapters in the current regulations — the draft elevates them, showing that the regulatory vision is expanding from market access towards the whole process of circulation and use. Companies whose quality systems were designed around licensing and registration only should read these two chapters as a preview of future obligations.

Insight two: the draft replaces the term Council with Authority. The current 2016 Regulations use Council throughout, referring to the Medicines Control Council; the draft uses Authority instead and introduces a definition of Chief Executive Officer (appointed under section 3 of the Act). This is the statutory reflection of the institutional transition, and it signals that future legal texts, forms and correspondence will be renamed wholesale, so document templates should be prepared for the switch rather than patched afterwards.

Insight three: the draft adds several dedicated provisions that the current regulations do not contain. The table of contents shows the draft covering custom-made devices (20), records for Class D devices, implantable custom-made devices or active custom-made devices (21), advertising (22) and exhibitions or evaluation (23), among others. The record-keeping provisions for Class D and for implantable or active custom-made devices are not separately listed in the current regulations, and they are expected to raise the record-keeping burden for high-risk and customised devices significantly.

Insight four: the Management chapter of the draft covers reprocessing and single use. Regulation 16 of the draft is titled Replacement, maintenance, refurbishment and single use of medical devices. This echoes MD07-2025/26 on the reprocessing of single-use devices published in 2025 — showing that the topic will have a more explicit home in the new framework, and that reprocessing programmes should be designed with that future provision in mind.

Insight five: the draft is not in force, and further revision is possible. Official information indicates that the draft is undergoing review by independent experts. The practical estimate is that companies should use it as a directional reference (adjusting systems and records in advance), but all submission actions must continue to follow the 2016 Regulations and SAHPRA’s current guidance; submission strategy should not be changed in anticipation of draft provisions that may themselves still change.

4. Practical recommendations

1. Continue applying Notice 1515 of 2016 in submissions: the draft has no current legal effect.
2. Build record-keeping capability in the direction of the draft: Class D records and custom-made device records.
3. Track the terminology switch from Council to Authority: future documents and forms will be updated wholesale.
4. Use the Management and Supply chapters as a reference for extending the quality system.
5. Follow the progress and conclusions of the independent expert review.
6. Subscribe to the Government Gazette: new regulations will be published by notice.

5. Verification checklist

• □ The current regulations have been confirmed as Notice No. 1515 (9 December 2016, 29 regulations)
• □ GN 435 (21 May 2021, 28 regulations) has been confirmed as a draft that is not in force
• □ The submission strategy follows the current regulations and has not been changed in anticipation of the draft
• □ Class D and custom-made device record capabilities have been assessed in the direction of the draft
• □ The terminology switch from Council to Authority is being tracked
• □ The Supply and Management chapters are included in quality system extension planning
• □ The progress of the independent expert review is on the monitoring list
• □ A Government Gazette subscription is in place to track new regulations

Regulatory information verified as of 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the official sources listed in the legal basis section above as published on that date; where official documents have been updated, the most recently published version prevails.

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• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway argumentation, technical documentation and essential principles conformity argumentation, labelling and instructions for use localisation in English, and support for post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.