The Importer/distributor already has a manufacturers license and wishes to resell to a wholesale company based in SA. The wholesale company has a wholesale license. The Antigen assay is already Section 21 approved and is listed on the SAHPRA website. Wholesale companies don’t do listings. They will however have to have a wholesale license that specifically allows them to sell Class D medical devices. Nothing more should be required. As long as the Importer/Manufacturer/Distributer has the product listed and approved the wholesaler need not duplicate the process as long as they have the required class on their license.
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