South Korea - Draft Amendments to the Enforcement Rules of the Digital Medical Devices Act following the enactment of the Digital Medical Devices Act

​The Ministry of Food and Drug Safety (MFDS) has announced draft amendments to the Enforcement Rules of the Digital Medical Devices Act following the enactment of the Digital Medical Devices Act (Law No. 20139; promulgated on January 23, 2024, and effective on January 24, 2025, or January 24, 2026).

- Establish detailed procedures and criteria for the certification of performance and distribution management of digital medical and health support devices.

Specify legal obligations related to recall, replacement, disposal, discontinuation, and public disclosure of these devices.

- Reporting and Modifications (Article 47):

- Performance Certification Procedures and Standards (Article 47-2):

- Designation of Performance Testing Agencies (Article 47-3):

- Distribution Management Plan (Article 47-4):

- Recall, Replacement, Disposal, or Sales Suspension (Article 47-5)​