Medical device registration in African/Asian countries


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Hello everyone :bigwave:

Need your help to understand medical device regulation in African countries?

1. Is there any collaboration between national medicines regulatory authorities available in African countries apart from ZAZIBONA?

2. If you can indicate if a regulatory affairs environment is establish and enforced that is not related to the one in South Africa (SAHPRA, formerly MCC) for the applicable countries: Angola, Botswana, Democratic republic of Congo, Ethiopia, Kenya, Malawi, Mauritius, Mozambique, Namibia, Tanzania, Uganda, Zambia, Zimbabwe?

3. What are all the African countries that follow South African medial device regulations (SAHPRA)?

Thanks in advance,
Hello! I can tell you that Ethiopia, Mozambique and Tanzania have regulatory authorities and a well establish procedure.

Democratic Republic of Congo is very informal to regulate the product, you should consider submitting a formal enquiry to ask about the requirements for your product.

Kenya, is a listing in the PPB and quite fast. The IVDs will require registration soon.

Namibia only regulates medicines up today, but you can ask for a formal statement declaring that your product is not regulated.

I hope this helps.


Starting to get Involved
Dear Apuigvert,

Thank you so much for the valuable information.

Do you have any information on the IVD regulations in Angola?

Thanks in advance!

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