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17 Nov

Posted at 12:50h in

This guideline sets out requirements and recommendations for radiation safety associated with the use of ultra-portable diagnostic X-ray equipment. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, efficacy, and quality of X-ray equipment. The Hazardous Substances Act, 1973...

10 Nov

Posted at 08:57h in

This document provides guidance regarding safe disposal and destruction of medicines and scheduled substances by health facilities in accordance with Regulation 44 of the General Regulations of the Medicines and Related Substances Act, 101 of 1965, and relevant waste legislation. To ensure the correct handling...

31 Oct

Posted at 14:48h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (Categories A and D) containing specified substances. Regarding Category D medicines, the guidance provided herein pertains to general content requirements. Any specific technical guidance indicated in...

27 Oct

Posted at 17:36h in

All guidelines adopted by the South African Health Products Regulatory Authority (SAHPRA) from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) must be read in conjunction with the current, non-draft version of SAHPRA’s Guide to Good Manufacturing Practice for...

01 Oct

Posted at 14:31h in

The purpose of the document is to guide the implementation of global standards for product identification, data capture, and data sharing. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The implementation of unique...

09 Sep

Posted at 10:34h in

This guideline is intended to provide recommendations to Manufacturers, Importers, Exporters, Distributors, and Holders of certificates of Registration (HCR) of medical devices. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and performance of medical devices. It is...

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...