South Korea - Notification of Draft Partial Amendment to the Enforcement Regulations of the Medical Device Act

This amendment is intended to ensure patients' medical choices by enabling the early market entry of newly developed medical devices and enhancing the quality and infrastructure of medical devices through an increase in authorization and review personnel. It aims to rationalize the fees for newly developed medical devices. Additionally, it seeks to improve regulations by reflecting recommendations from the evaluation of factors that may infringe upon personal information and by preventing the repetitive submission of qualification documents for medical device quality managers. With the amendment of the Medical Device Act (Law No. 19608, announced on August 8, 2023, and taking effect on February 9, 2025), which introduces administrative dispositions and a reporting system for medical device promotional personnel, this amendment aims to specify the administrative disposition standards for these personnel and establish the necessary fees for implementing the notification system for them.

Main Contents

1. Revision of authorization fees for newly developed medical devices

2. Revision of pre-review fees for newly developed medical devices

3. Establishment of fee reduction regulations for newly developed medical devices

4. Providing grounds for exemption from submitting qualification documents upon reemployment of quality managers

5. Reflecting administrative disposition standards for false reporting by medical device manufacturers, importers, repairers, sellers, and lessors

6. Establishing administrative disposition standards for medical device promotional personnel

7. Establishing standards for notification fees by medical device promotional personnel (including changes)​​