South Korea - Proposed Establishment of the “Enforcement Rule of the Digital Medical Products Act”

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

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

 - the scope of and classification standards for digital technology

 - permission (certification and reporting) considering the characteristics of digital medical devices

 - clinical trials (clinical performance tests)

 - cancellation or correction order regarding confirmation/investigation of compliance with quality control standards 

 - labeling, follow-up management methods and procedures

 - certification of excellent management systems

 - manufacturing and import of medicines combined with digital technology

 - impact assessment for supporting the development of digital medical products

 - matters regarding fees for digital medical devices​​