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.

Requirements for existing devices have not yet been adjusted

The MFDS is expected to issue a separate revision stating any additional renewal requirements for medical devices that are already authorized (or will be prior to October 8). Previous to this amendment of the law​, manufacturers of Class II and higher devices were required to renew Korea Good Manufacturing Practice (KGMP) certification every three years, but marketing authorizations did not expire.

Additional South Korean medical device regulatory resources from Emergo by UL:

• South Korean MFDS medical device registration consulting
• Korea Good Manufacturing Practice (KGMP) quality system support
• Whitepaper: Medical device registration in South Korea
• Regulatory process chart: MFDS approval for medical devices