Archive
25 Jan Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs
Posted at 13:03h
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices and In Vitro diagnostics (IVDs). It represents the South African Health Products Regulatory Authority current...
25 Jan Extension – Use of acknowledgement letter in lieu of a licence
Posted at 12:54h
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2020 Mar...
25 Jan Guideline on Medical Device Quality Manual
Posted at 12:53h
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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 Guideline for Classification of Medical Devices and IVDs
Posted at 12:52h
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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...