South Korea’s Ministry of Food and Drug Safety (MFDS) have published revised guidance for medical device authorisations.
Any authorisation issued for a medical device after 8 October 2020 will only remain valid for five years. This change will apply to all devices classes obtained through notification or pre-market approval.
Under the new regulation, manufacturers will be able to renew the authorisation for another five years. To be eligible for renewal, registration holders must have imported the device into South Korea within the authorisation period.
Previous, manufacturers of Class II and above devices were required to renew Korea Good Manufacturing Practice (KGMP) certification every three years, but marketing authorisations did not expire.
Additional renewal requirements for devices authorised before 8 October are expected to be released by the MFDS.