The Ministry of Food and Drug Safety (MFDS, formerly known as the Korea Food & Drug Administration or KFDA) is 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, renamed and upgraded to a ministry.
The MFDS is in charge, among others, of the approval of medical devices, of GMP standards and pre and post-market management 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
Some of the most important regulations for medical devices in the South Korea are:
- Medical Device Act - Act No.12107, Aug. 13, 2013 (Korean)
- Enforcement Decree of the Medical Devices Act - Presidential Decree No. 24480, March 23, 2013 (Korean)
- Regulation for Medical Device Approval, Notification, Review - MFDS Notification No. 2013-212, Aug. 29, 2013 (Korean) with attached table
- Regulations for Reviewing Technical Document, etc. of Medical Device - Attached Table
A full list of MFDS regulations can be found here.
- Website: http://www.mfds.go.kr/eng/index.do