Episode Details

This episode breaks down South Korea's Ministry of Food and Drug Safety (MFDS) Notice No. 2026-63, which details new evidence requirements for obtaining a post-market study exemption. Effective August 31, 2026, this notice affects manufacturers of new and orphan medical devices. We explain the specific criteria for demonstrating sufficient overseas use, including the required post-market clinical experience, safety information, and international sales history. This episode provides actionable guidance for regulatory and market access teams on how to leverage existing global data to meet these new standards and streamline entry into the Korean market. Key Questions: - What is MFDS Notice No. 2026-63 and who does it affect? - How can manufacturers of new or orphan medical devices gain an exemption from post-market studies in South Korea? - What specific types of overseas clinical experience data are now required? - What safety information, including recall and adverse event data, must be submitted? - How much international sales history is needed to satisfy the new MFDS criteria? - What are the practical steps for compiling a successful exemption application? - How does this change impact market access strategy for South Korea? Sources: - https://www.pure-global.com/insights/korea-mfds-2026-63-post-market-study-exemption-evidence/ - https://www.pure-global.com/news/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech companies navigate complex market access challenges like those in South Korea. Our experts can develop a clear regulatory strategy for your device, leveraging pathways like the post-market study exemption. We use advanced AI tools to efficiently compile, manage, and submit the technical dossiers required by authorities like the MFDS, ensuring your global clinical, safety, and sales data is presented effectively. For help with your Korean market access strategy or any of our 30+ markets, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI tools and global device database at https://pureglobal.ai.