Medical Devices Archives - Page 13 of 13 - SAHPRA

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25 Jan

Posted at 12:53h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for a licence to manufacture, import, distribute and export a medical device, including In Vitro diagnostics medical devices (IVDs). It represents the South African Health Products Regulatory Authority’s current thinking on the...

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 12:46h in

This guideline provides an outline of the principles and process to be followed in the donation of medicines, medical devices, and in vitro diagnostics (IVDs). The guideline applies to both people and entities wishing to make donations and the recipients of such donations. The South African...

22 Aug

Posted at 21:41h in

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.   How to complete an application for Manufacturers of Medical...