The Korean Ministry of Food and Drug Safety (MFDS) has exempted (link in Korean) all Class I low-risk medical devices from quality system requirements previously necessary to obtain market authorization in South Korea.

Prior to September 16, 2013, Class I Special Control device manufacturers were subject to document audits to verify compliance with Korea Good Manufacturing Practice (KGMP) quality management system requirements.

Now, Class I manufacturers and their Korea License Holder authorized representatives may begin marketing their devices in Korea after electronic submission pre-market notifications to the MFDS. One less barrier to market entry for low-risk medical devices will no doubt drive more interest from foreign manufacturers in South Korea.

Stewart Eisenhart