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UAE Regulatory Overhaul: Unpacking Federal Decree-Law 38 for MedTech
This episode delves into the landmark changes introduced by the UAE's Federal Decree-Law 38 of 2024, which took effect on January 2, 2025. We explore the creation of the new Emirates Drug Establishment (EDE), the critical new requirements for importers and distributors, and what the one-year grace period means for medical device manufacturers looking to enter or remain in the UAE market. • What is the new Federal Decree-Law 38 of 2024 and when does it become effective? • How does the new Emirates Drug Establishment (EDE) change the regulatory landscape in the UAE? • What specific new rules…
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