SAHPRA licence renewals, retention fees and deadlines: a year on one page
A medical device establishment licence does not lapse in one dramatic moment. It slips on a date nobody had in their calendar. These are the dates that matter.
Last checked against its sources on 23 October 2026.
The dates
| When | What |
|---|---|
| Every year, on or before the last working day of June | Annual retention fee, from the year after the licence was approved |
| At least 90 days before expiry | Renewal application (regulation 6(3)(c)) |
| Five years from the date of issue | Licence expires (regulation 6(1)) |
Retention fees
Regulation 5(6) requires an annual fee. SAHPRA's annual retention fee notices (April 2025, and March 2026 for this year) set the due date as the last working day of June, and warn that a licence may be cancelled if the fee is not paid. The 2025 notice also charges interest on amounts outstanding from 1 August.
Fee amounts are set by the fees notice in the Government Gazette (GN 5856 of 12 February 2025 at the time of writing). Take the amount from SAHPRA's current notice, not from this page.
Renewals
Apply at least 90 days before the licence expires; SAHPRA's Q&A guideline adds that applications made after expiry are not accepted. Renewals already need an ISO 13485 certificate: that phase of SAHPRA's certificate requirement started on 1 June 2025.
Keeping the dates in front of you
- Put the June retention fee and the 90-day renewal date in a shared calendar, not one person's inbox.
- Plan the ISO 13485 certificate around the renewal: certification takes months, and a renewal needs it.
- Keep the payment proof with the licence records; it is part of the evidence.
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- Medical Devices Regulations, GN 1515, Government Gazette 40480 (9 December 2016)
- SAHPRA, annual retention fee notification (2 April 2025)
- SAHPRA, annual retention fee notice (26 March 2026)
- SAHPRA, SAHPGL-MD-07 v4: questions and answers on licensing of medical device establishments (21 May 2025)
- SAHPRA, ISO 13485 certificate as a prerequisite for the approval of a medical device establishment licence (MD01-2025/2026_v2, 18 September 2025)
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.