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South Korea MFDS Innovative Device Approval: The 240-Day Fast-Track Plan
South Korea's Ministry of Food and Drug Safety (MFDS) has renewed its commitment to the 'Medical Product Approval and Review Innovation Plan,' aiming to approve innovative medical devices within 240 days. This episode details the plan's three core components—a new detailed approval checklist, formal pre-submission meetings, and a parallel, rolling review system—and explores what these changes mean for manufacturers seeking faster market entry into South Korea. Key Questions: - How can you get your innovative medical device approved in South Korea in just 240 days? - What is the new MFDS…
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