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  • 1.  South Africa - Class A, non-sterile and non-measuring device

    This message was posted by a user wishing to remain anonymous
    Posted 28-Jan-2020 15:56
    This message was posted by a user wishing to remain anonymous

    Hello,
    Does anyone know if medical devices are regulated in South Africa? 
    Does SAHPRA enforce product registration for Class A devices ? 
    Many thanks


  • 2.  RE: South Africa - Class A, non-sterile and non-measuring device

    Posted 29-Jan-2020 03:08
    Dear Anon,

    The process of regulating medical devices is indeed in effect in South Africa. However, all the various regulatory considerations are not fully operational. SAHPRA is still on a quest to close out the holes in their system - a much bigger task than they envisaged I think. SAHPRA (previously MCC) has a profound understanding of Pharma but very few expertise in devices.

    That being said, no product class has been called up for registration as yet (this date keeps getting shifted and to be honest, I am not sure when this will happen. Call up for registration will be risk-based and will start at the Class D devices eventually ending with Class A.

    What is required is to License your establishment with SAHPRA (I can help more with this if needed) proving the devices you intend to place on the SAn market is registered in a jurisdiction that is recognised by SAHPRA (US, EU, Japan, Brazil, China, Australia, etc.). Once you have done this you can partner with a licensed distributor for the sale of your product.

    Good luck and let me know if I can help with anything else.
    Regards

    ------------------------------
    Malcolm Applewhite
    QA/RA Manager
    Cape Town
    South Africa
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    Original Message


  • 3.  RE: South Africa - Class A, non-sterile and non-measuring device

    Posted 29-Jan-2020 17:50

    Hello,

    The Medical device and IVD regulatory framework is very new and not yet fully implemented, although the legislation has been enacted. I was having difficulty getting a response from the agency, but it was due to organizational issues.

    Manufacturers must obtain a license to import and/or export a medical device and/or IVD in SA per Registration of Medical Devices and IVDs, p. 9; Medicines and Related Substances Control Act, 1965, Art. 22C; see also General Regulations, Art. 8.  All medical devices, except custom made devices, and all IVDs shall be registered with the Council. See General Regulations, Art. 9-12.

    The registration and listing requirements are: TDS, IFU, AR letter, EC Cert from NB, and EC DoC by Mfg.

    Renewals are annually.

    However, a colleague told me that they do not have any notifications. I will recommend to at least notify them, so you are covered. 

    Thx,



    ------------------------------
    Aurelia Brownridge
    Sr. Regulatory Affairs Specialist
    San Diego CA
    United States
    ------------------------------

    Original Message


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