South Korea - Amendments to the "Enforcement Rule of the Medical Devices Act"

South Korea Ministry of Food and Drug Safety (MFDS) announced amendment of the "Enforcement Rule of the Medical Devices Act" as stated below:

Although the Medical Devices Act specifies that the renewal of approvals/certifications/reporting of manufacturing or imports is mandatory, the renewal system has not been operated effectively since the Act did not stipulate the setting of validity period for the renewals. Thus, the revised Medical Devices Act, promulgated to be in effect on 8 October 2020, sets a five-year validity period for the renewals. In this regard, the revised Enforcement Rule of the same Act sets forth the details of procedures and methods for the renewal.

Proposed date of adoption
To be determined

Proposed date of entry into force
To be determined

Final date for comments
07/08/2020