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MFDS Korea Post-Market Study Exemption: Leveraging Overseas Data Under Notice 2026-63
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…
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