The establishment licence
The Section 22C establishment licence, the 6–8-week timeline, 3,000 active licences, and mandatory ISO 13485 at renewal since June 2025.
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South Africa SAHPRA: Device Licensing2026 Field Guide
The establishment licence, the call-up horizon, and the reliance route — with the SAHPRA practice you need.
- Active licences
- 3,000
- Unregulated devices
- 200k+
- Licensing
- 6–8 wks
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The call-up horizon
200,000+ devices still unregulated — the phased risk-class call-up, and the voluntary feasibility study now testing the approach.
The reliance route
Originating approval in six recognised jurisdictions, accredited CAB assessment, the SA Authorised Representative, and the A–D class system.
Sources & scope
- meddeviceguide.com, South Africa SAHPRA Medical Device Establishment Licenses (3,000 Active).
- spotlightnsp.co.za, Medical devices aren't regulated in SA, but that is set to change (Sep 2025).
- SAHPRA, Reliance Medical Device Registration Voluntary Feasibility Study Pathway.
This guide is market-access intelligence, not regulatory or legal advice. SAHPRA licensing practice, call-up timing, and feasibility-study rules change — professional review is required before business use.
Market Access Strategy Session
South Africa on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your SAHPRA route — establishment licensing, call-up preparation, and reliance strategy.
Professional review is required before business use.
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