The MFDS is planning to partially revise the enforcement rules of the Medical Devices Act.
Public comments will be accepted until February 5, 2024.
- Considering the unnecessary technical document review for the approval of Class 1 and Class 2 export medical devices, the process for permit-targeted Class 1 and Class 2 export medical devices will be eased to certification and notification.
- In the event of the discovery of foreign substances in medical devices, detailed regulations will be established regarding the criteria, methods, and procedures for disclosing facts related to the discovery of foreign substances, allowing for the publication of such information.
- Medical device importers are required to have warehouse and testing facilities. However, facility standards for software medical device importers, which do not require warehouse and testing facilities, will be revised.
- The renewal fees for medical device manufacturing and import permits will be determined.
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