UAE medical device and IVD market access under MOHAP generally follows two main pathways: product classification and product registration. Classification determines the regulatory status, risk profile, and whether full registration is required, while registration involves site and/or product dossier review where applicable.
Typical documents include LOA, CE/ISO/FSC or CFG certificates, labeling and leaflet files, catalogue, product photos, market status evidence, product list, and composition certificate or MSDS where applicable.
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