MFDS - South Korea Ministry of Food and Drug Safety

The Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) is the governmental agency that regulates food, pharmaceuticals, medical devices, and cosmetics in South Korea. It was founded in 1996 and, with the creation of Medical Devices Management Division and Bioproduct Technical Support Division restructured, restructured in 2005 only to be restructured again in 2013, when it was renamed and upgraded to a ministry.

The MFDS is in charge of the approval of medical devices, GMP standards, and pre- and post-market management of the medical device classification process. The section of the MFDS in charge of medical devices is the Medical Device Safety Bureau, made up of the following divisions:

  • Medical Device Policy Division
  • Medical Device Management Division
  • Medical Device Quality Division

A list of MFDS regulations can be found here on our website.

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