South Korea - Proposed Amendments to the "Enforcement Rule of the Digital Medical Products Act"

​The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea proposes amendments to the following provisions of the Enforcement Rule of the Digital Medical Products Act.

- Notification and notification of change of digital medical or health support devices

- Standards and procedures for performance certification of digital medical or health support devices

- Standard and procedures for designating performance inspection agencies

- Formulation and implementation of distribution management plans for digital medical or health support devices

- Issuance of Order and publication regarding recall, exchange, destruction, or suspension of distribution of digital medical or health support devices.