ISO-13485 Compliance OS · Free guide · iso13485-compliance.co.za/guides/sahpra-iso-13485-phases
SAHPRA's five phases on one page
SAHPRA is rolling out mandatory ISO 13485:2016 certification, or the latest version, in five phases. Here are the dates and what each phase covers, so you can find yours.
Last checked against its sources on 24 October 2026.
Which area is your biggest gap? The free Gap Heatmap: 27 questions, about 4 minutes, nine ISO 13485 areas.
Take the free Heatmap →The five phases
| Phase | From | What it covers |
|---|---|---|
| 1. Preparation | 1 April 2025 | Licence holders declared a certificate. No evidence was asked for. |
| 2. Renewals | 1 June 2025 | Renewals, for manufacturers and for distributors or importers. |
| 3. Companies already holding a certificate | 1 April 2026 | Holders "will be requested to submit". SAHPRA describes the requirement as mandatory. |
| 4. Amendments | 1 June 2027 | Amendments. |
| 5. All new applications | 1 April 2028 | All new applications. |
The phases are set out in SAHPRA's MD01 notice, dated 18 September 2025.
Who the phases name
Manufacturers and distributors or importers are named in the phases. This is not a manufacturer-only exercise.
Phase 3 is about companies that already hold a certificate. Find the phase that matches your own position before you plan around a date.
What it means in practice
When an inspector visits, your licence is what is at stake. The inspector's job is to see evidence, not intentions.
Most gaps are not missing procedures. They are procedures nobody can prove are followed. The nine areas of the free Gap Heatmap are a quick way to see where yours are.
Read the source
This page is a summary, not a substitute. SAHPRA updates its guidance, so read the notice itself, linked below, and confirm which phase applies to you with SAHPRA or your certification body.
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
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 a software product. It does not warrant SAHPRA outcomes.
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.