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 Documentation (STED) files along with Korean technical files when applying for South Korean market authorization. Instead,following STED-related documentation from Class IV device market applicants would be required:

  • Flow charts showing each step of the device’s manufacturing process;
  • Detailed explanations of processes that could affect the performance and/or effectiveness of the device;
  • Descriptions and indications of all sterilization methods, standards, validation cycles and conditions utilized in the device’s manufacturing process.
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