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

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 Authority (SFDA) announce on July 28, 2026? - Why is the resale or auction of used medical devices a compliance risk in Saudi Arabia? - Which specific regulation governs the handling of used medical devices? - What documentation must be provided when transferring a used medical device? - Does this warning apply to donations and lending as well as sales? - What is a Medical Device Marketing Authorization (MDMA) and is it required for used devices? - What are the potential consequences of non-compliance with SFDA's rules? - What immediate steps should facilities with used medical devices take? Sources: - https://www.lexismiddleeast.com/news/saudi-arabia-sfda-warns-against-resale-of-used-medical-devices/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking market access in Saudi Arabia and over 30 other countries. Our local experts and advanced AI tools can help you navigate complex SFDA requirements, including those for used medical devices. We assist with regulatory strategy, technical dossier preparation, and act as your local representative to ensure full compliance. With Pure Global, you can streamline your registration process and maintain your market presence confidently. Learn more about our free AI tools and global database at https://pureglobal.ai or contact us at [email protected] and https://pureglobal.com.