South Korea amended to the enforcement Rule of the Medical Devices Act

Ministry of Food and Drug Safety is amending 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.

Products covered:Medical Devices

HS Code:9018, 9020

Proposed date of adoption:To be determined

Proposed date of entry into force:To be determined

Final date for comments:60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.