SFDA Used Medical Device Resale: New Warning and Compliance Rules in Saudi Arabia

Medical Device Global Market Access · Aug 2, 2026 · 5m

This episode details the Saudi Food and Drug Authority's (SFDA) public warning issued on July 28, 2026, regarding the non-compliant resale, auction, lending, or donation of used medical devices. We explore how this action enforces Article 20 of Regulation No. 1/1443 and what it means for healthcare establishments. We cover the specific requirements, including the need for a valid Medical Device Marketing Authorization (MDMA) and the obligation to transfer complete technical documentation to the new user to ensure device safety and performance. Key Questions: - What did the Saudi Food and Drug…