Tag: South Korea

Healthcare, Industry News, Medical Devices

Ministry of Food and Drug Safety Korean reduces submission requirements for high-risk devices

South Korean MFDS have reduced the registration submission requirements for Class-IV medical devices. This noticeis expected to reduce submission preparation timeframes for Class IV device applicants, and potentially eases South Korean market entry. As per the noticefrom MFDS, manufacturers of Class IV devices will no longer be required to prepare and submit full Summary Technical […]

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