South Korea - Draft of Enforcement Regulations of the Digital Medical Products Act

​Korea Ministry of Food and Drug Safety announces the draft of Enforcement Regulations of the Digital Medical Products Act to specify matters necessary for handling, managing, and supporting the manufacturing, importing, etc. of digital medical products, as the "Digital Medical Products Act" has been enacted (Act No. 20139, promulgated on January 23, 2024, and implemented on January 24, 2025).

This Act aims to specify matters delegated by the Act and matters necessary for its implementation.

Final date for comments: September 9, 2024​