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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 12:46h in

This guideline is provided to outline the principles and process to be followed in the donation of medicines, medical devices and in-vitro diagnostics (IVDs). The guideline is applicable to both persons and entities wishing to make donations and the recipients of such donations. The South...

22 Aug

Posted at 21:41h in

Previously 6.21 An application form for the purpose of obtaining a licence or renewing a licence in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, Sections 22C and 22D....