MFDS Opens a New Era of Innovation in Medical Product Approval and Review with 240-Day Approval Target
The MFDS announced a new initiative to streamline medical product approval and review processes with a target approval timeline of 240 days. This reform aims to accelerate the innovation pathway for medical devices and related products.
🔖 Status: announced
This reform is part of the MFDS's ongoing programme to modernise and strengthen the South Korea medical device regulatory framework. Monitor the official source for updates on timelines, consultation opportunities, and implementation guidance. Where relevant, begin assessing potential impacts on your existing registrations, technical documentation, and compliance timelines so your organisation is prepared when the reform takes effect.
View official source ↗