What are the regulatory requirements for importing IVD products?

In order to import an IVD, you need to have a distributor’s licence: GUIDANCE DOCUMENT: (sahpra.org.za)

If you already have a distributor’s licence (or a manufacturer’s licence), you need to ensure that the IVDs that you want to import, are listed.  If it is not listed on the licence, you will need to amend the licence so that the IVDs are listed.

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