UAE mandates AED 1 million fine for medical product violations

Federal Decree-Law No. 8 of 2024 introduces AED 1 million fines for manufacturers, importers, and distributors of unregistered medical products in the UAE. The Ministry of Health and Prevention (MOHAP) enforces these penalties for any entity operating within the country. CFOs and operations directors must update compliance budgets to account for this enforcement power. The law requires strict adherence to national standards for the storage, pricing, and distribution of pharmaceuticals and health supplements. COO-level staff must review supply chain verification processes to block unauthorized items from facility inventories. The statute places the liability burden on the supplier and mandates documentation for every product batch. Hospital owners and procurement leads should audit pharmaceutical contracts to ensure compliance. MOHAP monitors clinical performance and product safety across public and private sectors. Entities that fail to update inventory systems face the AED 1 million fine and the potential suspension of operational licenses. MOHAP will release executive regulations with specific registration timelines in the coming weeks. Facility managers should track the official gazette for the implementation schedule. Organizations sourcing from international markets without local authorized agents must review supply agreements to avoid violations of the new regulatory provisions.