How is SaMD (Software as a Medical Device) Regulated in the UAE?

Summary Software as a Medical Device (SaMD) represents a rapidly growing segment of digital health innovation in the UAE. Under Federal Decree-Law No. 38 of 2024, which came into effect on January 2, 2025, SaMD is subject to comprehensive regulatory oversight by the Emirates Drug Establishment (EDE). Key points: Digital health tools that diagnose, treat, […]



















