ISO 13485 and SAHPRA guides

Plain answers for South African medical device importers, distributors and manufacturers, each linked to the document behind it.

• SAHPRA medical device establishment licence: what you need, step by stepWho needs a SAHPRA medical device establishment licence, which form to use, what the application must include, and the quality system behind it.
• ISO 13485 certification in South Africa: what SAHPRA now expectsSAHPRA is phasing in an ISO 13485 certificate as a prerequisite for medical device establishment licences. Who it applies to, the dates, and where to start.
• ISO 13485 checklist for South African importers, distributors and manufacturersAn ISO 13485 checklist for South African medical device importers, distributors and manufacturers: nine areas and the evidence each one needs.
• SAHPRA inspection preparation: the records your quality system should be able to showPreparing for a SAHPRA inspection or ISO 13485 audit: the records a medical device establishment should be able to produce, area by area.
• The ISO 13485 Quality Manual and SOP list for your licence typeWhich ISO 13485 documents a South African medical device importer, distributor or manufacturer needs: the Quality Manual and SOPs, with the clause behind each.
• QMS software for medical devices: spreadsheets, consultants or a system that staysSpreadsheets, a consultant or QMS software: how South African medical device companies can run an ISO 13485 system, and what each leaves behind.
• SAHPRA licence renewals, retention fees and deadlines: a year on one pageWhen a SAHPRA medical device establishment licence must be renewed, when the annual retention fee is due, and what happens if a deadline is missed.
• Medical device vigilance and adverse event reporting in South AfricaWho reports medical device adverse events to SAHPRA, the published timelines, the form and guideline to use, and where reports and recalls are sent.

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.