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09 Sep

Posted at 10:33h in

This guideline is intended to clarify the requirements of conducting a clinical evaluation of a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...

09 Sep

Posted at 10:07h in

This guideline is intended to clarify the requirements of conducting a clinical investigation in a medical device in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and performance of medical devices under clinical investigation. It...

20 Nov

Posted at 09:03h in

This guideline intends to narrate the critical framework of sealing and unsealing hazardous substances. It stipulates all enforcement actions necessary, according to the Hazardous Substance Act, 15 of 1973 with respect to Grouped Hazardous Substances, related regulations and prescribed licence conditions, that may be imposed...

16 Jul

Posted at 12:01h in

This guideline is intended to provide guidance to applicants who intend to apply as co-applicants for the registration of a medicine. It represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on managing applications for registration where there is more than...

24 Apr

Posted at 11:19h in

This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to import and /or distribute substances listed in the schedules in terms of the Medicines Act, intended for use in the manufacturing and/or compounding of medicines or scheduled...