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...