On February 28, 2025, the Enforcement Rule of the Digital Medical Products Act was established to define the delegated matters and necessary implementation details following the enactment of the Digital Medical Products Act (effective January 24, 2025) and its Enforcement Decree (effective January 24, 2025).The key provisions of the Enforcement Rule include:1) Specific criteria for the classific..

On January 24, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea established the guideline for the approval and review of standalone digital medical device software utilizing usability in accordance with the implementation of the Digital Medical Products Act.  The guideline was created to clearly explain the scope and criteria for usability evaluation when approving or reviewing standal..