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Navigating the UAE's MOHAP to EDE Transition
Welcome to the DDReg Knowledge Capsule. In this episode, we unpack the historic shift in the UAE’s healthcare regulatory framework as the Emirates Drug Establishment (EDE) takes over medical device oversight from the Ministry of Health and Prevention (MOHAP). Established under Federal Decree-Law No. 38 of 2024, the EDE centralizes compliance across all seven emirates. We discuss critical updates for manufacturers and distributors, from key technical dossier requirements (such as CE Marks and FDA clearances) to the new 45-working-day completion timeline and the 5-year marketing authorization…
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