Post-Market Surveillance and PMCF Studies under SAHPGL-MD-18

1. Key takeaways

On 9 September 2025 SAHPRA published its guidance on Post-Market Surveillance and Post-Market Clinical Follow-up Studies (SAHPGL-MD-18, version 1), addressed to manufacturers, importers, exporters and distributors of medical devices as well as holders of certificates of registration (HCR), setting out recommended practice for post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies. The publication of this guidance is an important signal: before product registration has even been called up, SAHPRA has already formalised the post-market stage. Companies should read the document not as a distant aspiration but as the template against which future inspections and review questions will be framed, and they should build the described PMS and PMCF structures into their quality systems now, while processes can still be designed calmly rather than under the pressure of an imminent enforcement deadline.

2. Legal basis

3. Expert insights

Insight one: PMS and vigilance are not the same thing, but they draw on the same data source. Vigilance under SAHPGL-MD-03 deals with the reporting timelines for individual adverse events; PMS under SAHPGL-MD-18 deals with the systematic and proactive collection and evaluation of information. The former is passively triggered, the latter is proactively planned. Companies should support both from a single data source rather than building parallel systems, because a divided data architecture leads to inconsistent figures in vigilance reports on the one hand and PMS summaries on the other, which is exactly the kind of discrepancy an inspector will pursue.

Insight two: PMCF is the clinical extension of PMS. Post-market clinical follow-up studies are used to continuously confirm the clinical safety and performance of a device after it has been placed on the market, and are especially relevant for implantable devices, Class C and Class D devices, and long-term-use devices. The practical estimate is that not every device needs a PMCF study, but every device needs some form of PMS. The decision on whether a dedicated PMCF study is warranted should be documented, with the clinical evaluation identifying the residual uncertainties that only post-market data can close.

Insight three: the inclusion of HCRs among the addressees shows that the framework is designed for a future in which registration numbers exist. SAHPGL-MD-18 expressly lists HCRs (holders of certificates of registration) among the parties to which it applies. Writing HCRs into a guidance issued in a market that has no product registration numbers yet can only be read as laying the groundwork for the post-call-up scenario. It is one more signal that the registration regime is approaching, and that post-market duties will attach to registration holders from the outset rather than being bolted on later.

Insight four: PMS outputs flow back into risk management and essential principles conformity. The conclusions of PMS should update the risk documentation and re-test conformity with the essential principles. This parallels the logic of Article 16(3) of the Macao, China framework on post-market research and risk control plans — the post-market phase is not the end of the lifecycle but a stage in which evidence is continuously refreshed. Treating PMS as a standalone annual report, disconnected from the risk file, defeats the purpose of the guidance.

Insight five: reliance can also apply to the post-market stage. SAHPGL-MD-22 expressly lists post-market activities and market surveillance among the regulatory activities to which reliance may apply. The practical estimate is that PMS and PMCF data already generated in other markets can support the South African PMS, provided that local applicability is argued — including differences in user populations, clinical practice, and the South African health system context.

4. Practical recommendations

1. Build a PMS plan aligned with SAHPGL-MD-18: covering information collection, analysis and evaluation as three distinct stages.
2. Assess PMCF needs for high-risk and implantable devices: document the reasoning either way.
3. Share the data source between PMS and vigilance: avoid running two disconnected systems.
4. Route PMS conclusions back into the risk documentation and the essential principles matrix.
5. Reuse foreign PMS data after arguing local applicability: keep the argumentation on file.
6. Feed PMS outputs into the annual management review: so leadership sees the post-market picture.

5. Verification checklist

• □ The current text of SAHPGL-MD-18 v1 (9 September 2025) has been obtained
• □ A PMS plan has been established (collection, analysis and evaluation as three stages)
• □ PMCF needs have been assessed for high-risk and implantable devices
• □ PMS and vigilance share a common data source
• □ PMS conclusions flow back into the risk management documentation and the essential principles matrix
• □ The local applicability of foreign PMS data has been argued and documented
• □ PMS outputs are included in the annual management review
• □ PMS records are archived in an auditable manner

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.

• Local resources in South Africa: GRZAN assists manufacturers from the Chinese mainland and other markets with SAHPRA medical device establishment licence (MDEL) applications and product registration preparation, including authorised representative (AR) scheme design, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification determination, technical documentation, and the setup of vigilance and adverse event notification mechanisms.
• 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.