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SAPHRA Guideline: Questions And Answers Licensing Of Medical Device Establishments

Recently this week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline On Questions And Answers Licensing Of Medical Device Establishments".

Medical devices in South Africa are regulated by the Medicines and Related Substances Act, 1965 (Act 101 of 1965), promulgated on 01 June 2017.


This Q&A document summarizes questions relating to the below-listed South African guidelines on licensing of medical device establishments and represents the Medicine Control Council’s current view.:

  • Guideline for a license to manufacture, import, export, or distribute medical devices and IVDs

  • License to act as a wholesaler of medical devices and IVDs and the application forms:

  • License Application to manufacture, import, distribute, or export medical devices

  • License Application to import, distribute or export medical devices

  • License Application to Wholesale Medical Devices

In order to know more details on "How to apply for a medical device establishment license?", "Which documents must be submitted when applying for a medical device establishment license?" and some more important questions click this LINK.





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