Korea | Amendments to the "Enforcement Rule of the Medical Devices Act"
Title of document
Amendments to the "Enforcement Rule of the Medical Devices Act" (29 page(s), in Korean)
The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea 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.
Notifying member: Korea, Republic of
The amendments aim to address the limitations found in the operation of the Act
Ministry of Food and Drug Safety
- Submission: 19/06/2020
- Reception: 19/06/2020
- Distribution: 19/06/2020
- Final date for comments: 18/08/2020
- Proposed date of adoption: N/A