Saudi Arabia SFDA Medical Device Bundling: Key Changes in Guidance MDS-G-028

Medical Device Global Market Access · Jul 15, 2026 · 5m

Saudi Arabia's SFDA has released a new guidance document, MDS-G-028, effective May 3, 2026, which significantly changes the rules for bundling medical devices. This episode breaks down the updated criteria for grouping devices into families, systems, and procedure packs for a single Medical Device Marketing Authorization (MDMA). We discuss the impact on submission strategies, costs, and documentation requirements, and provide practical steps for manufacturers to ensure compliance and maintain market access. Key Questions: - What is the new SFDA guidance MDS-G-028 on medical device bundling? -…