Medical device vigilance and adverse event reporting in South Africa
The reporting clock starts when you become aware of an event, not when someone gets round to telling the quality manager. Whether your process can keep up is the real question.
Last checked against its sources on 23 October 2026.
Who reports
Regulation 17 of the Medical Devices Regulations places the duty on the Authorised Representative of the licence or registration certificate holder. SAHPRA's FAQ adds that reports should also be passed to the original manufacturer.
The timelines SAHPRA publishes
| Event | Report within |
|---|---|
| Serious public health threat | 48 hours |
| Death or serious deterioration in health | 10 calendar days |
| Other reportable events | 30 days |
| Field safety corrective action: follow-up report | 30 days after the initial notification |
These periods are from SAHPRA's medical device adverse events and FSCA FAQ. The Regulations leave the periods to SAHPRA, and the governing guideline is SAHPGL-MD-03 (Guideline for Medical Device Adverse Event Reporting, v4, 13 December 2024). Read the guideline before you set your own procedure's timelines.
Forms and addresses
- Report on form GLF-MD-11A, completed as guideline SAHPGL-MD-11 describes.
- Adverse events and field safety corrective actions go to mdvigilance@sahpra.org.za.
- Recalls go to recalls@sahpra.org.za (the Regulatory Compliance Unit), not to the Medical Device Unit (SAHPRA communication MD04-2026/27).
Where processes break
The failure is rarely the report itself. It is the hand-off: a complaint logged by sales that is never assessed for reportability, a distributor who hears about an event and waits for the manufacturer, a clock started late because nobody knew it had started. In ISO 13485 terms this is clause 8.2.2 (complaint handling) and 8.2.3 (reporting to regulatory authorities): every complaint is assessed for reportability, and the decision is recorded either way.
Find your three highest-impact gaps before your next inspection.
The free Gap Heatmap: 27 questions across nine ISO 13485 areas, about 4 minutes. You get a readiness score, the gap between what you say you have and what you could show an inspector, and your biggest gaps ranked, each mapped to its clause. Free, no card.
Start my free Gap Heatmap →Sources
- Medical Devices Regulations, GN 1515, Government Gazette 40480 (9 December 2016)
- SAHPRA, FAQ: medical devices adverse events and FSCA
- SAHPRA, MD04-2026/27: contact details for SAHPGL-MD-03, medical device vigilance (24 June 2026)
This guide summarises published documents; it is not legal or regulatory advice. Check the source before you rely on a date or requirement.
ISO-13485 Compliance OS is software, not a regulator, notified body or certification body, and is not affiliated with or endorsed by SAHPRA. Nothing here is legal advice; no regulatory outcome is promised or guaranteed.