South Korea - Proposed Establishment of the Enforcement Decree of the Digital Medical Products Act

​South Korea Ministry of Food and Drug Safety (MFDS​) proposed establishment of the “Enforcement Decree of the Digital Medical Products Act”.​

The purpose of this Decree is to prescribe matters mandated by the Digital Medical Products Act for its enactment and enforcement. The matters are as follows:

 - details necessary for establishment and implementation of a comprehensive plan for digital medical products

 - facility standards for medicines combined with digital technology

 - procedures and methods for designating institutions for fostering professional human resources, centers for regulatory support, and agencies for certification

 - processing of sensitive information and personally identifiable information

 - other matters​