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

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? - How does MDS-G-028 change the rules for creating a "device family" in Saudi Arabia? - What are the updated definitions for "systems" and "procedure packs"? - How will these changes affect MDMA submission costs and timelines for manufacturers? - What new documentation is required to justify a device grouping to the SFDA? - Which types of medical device companies are most affected by these new rules? - What are the implications for existing MDMAs upon renewal? - What practical steps should regulatory teams take now to prepare for this change? Sources: - https://www.complianceandrisks.com/blog/gcc-medical-devices-regulation-2026-updates-for-manufacturers/ - https://www.sfda.gov.sa/sites/default/files/2024-05/MDS-G-028.pdf - https://www.sfda.gov.sa/en/medical-devices How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech and IVD companies navigate complex global markets like Saudi Arabia. Our team of local experts, supported by advanced AI, can help you develop a compliant regulatory strategy, prepare robust technical dossiers, and act as your local representative. We streamline the market access process, helping you manage submission strategies and ensure compliance with new requirements like MDS-G-028. For support with your global expansion and to access our free AI regulatory tools and database, visit us at https://pureglobal.com, contact us at [email protected], or explore our tools at https://pureglobal.ai.