UAE Regulatory Overhaul: Unpacking Federal Decree-Law 38 for MedTech
Medical Device Global Market Access · Pure Global
September 24, 20252m 39s
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Show Notes
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 apply to Marketing Authorisation Holders regarding importers and distributors?
• Are both pharmaceuticals and medical devices now governed by the same law?
• How long is the grace period for companies to comply with the new regulations?
• What key areas, like contracts and quality systems, must be updated before the January 2, 2026 deadline?
• Why is the UAE making these significant changes to its regulatory framework?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.