South Korea – South Korea adds renewal requirement for new medical device authorizations

MFDS issues significant revision to Medical Devices Act

South Korea’s Ministry of Food and Drug Safety (MFDS) published a revision to Article 49 of the Medical Devices Act (Act No. 17248, link in Korean) on April 4, establishing that medical device authorizations issued by the MFDS after October 8, 2020 will only remain valid for five years. This change applies to all device classes, whether authorization was obtained through notification or pre-market approval.

Under the revised law, it will be possible for manufacturers to renew device authorizations for subsequent five-year periods. A further requirement stipulates that registration holders must have imported the device in question into the South Korean market within the authorization period in order to be eligible for renewal…