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25 Jan

Posted at 12:52h in

This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors and wholesalers, and registration of medical devices and IVDs. It represents the Authority’s current thinking on the safety, quality and performance of medical devices and...

25 Jan

Posted at 12:49h in

This guideline provides a reference document detailing the regulatory requirements for reporting of an adverse event for a medical device (including an IVD) in South Africa and describes the information to be supplied to the South African Health Products Regulatory Authority (SAHPRA). This guideline is...

25 Jan

Posted at 12:22h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of...

25 Jan

Posted at 11:58h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Health Supplements. It represents the South African Health Product Regulatory Authority’s current thinking on the quality, safety, and efficacy of these medicines. It is not intended as an...

25 Jan

Posted at 11:56h in

This document has been prepared to serve as guidance to stakeholders regarding the regulation pathway of Category D medicines ( complementary medicines registration. It represe...

25 Jan

Posted at 10:36h in

This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information...

25 Jan

Posted at 10:24h in

This guideline provides recommendations to applicants who intend to submit applications for the registration or authorisation of medicines intended to be available to those affected by a public health emergency. It represents the current thinking of the South African Health Products Regulatory Authority (the Authority)...

25 Jan

Posted at 10:20h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines and variations. It represents the Authority’s current thinking on medicines' safety, efficacy and quality. It is not intended as an exclusive approach....