The National Assembly in Korea approved a new Medical Device Act in April 30, 2003. Officially announed in May 29, 2003, the act is put into enforcement in May 29, 2004. Presently, medical devices in Korea are regulated under Pharmaceutical Affairs Act.

The new Act features strengthened post-market regulatory requirements on high-risk medical devices, such as recalls, mandatory tracking for devices implanted for one year or more. The executive branches responsible for implementing the new law are Ministry of Health and Welfare (MOHW) and Korea Food & Drug Administration (KFDA). Those agencies are known to work on implementing regulations that will unveil later 2003.

For an English translation of the new Act, please click here to send us e-mail.