South Korea - Proposed Amendment to the “Regulations on the Classification Categories of Digital Medical Products”

​The Ministry of Food and Drug Safety (MFDS) is amending the “Regulations on the Classification Categories of Digital Medical Products”.

Products that are not classified as medical devices but are designated as digital medical and health support devices aim to help maintain and improve physical and mental health. 

These devices measure, collect, monitor, and analyze indicators such as physiological metrics, body composition, movement data, and mental health data. 

They also analyze lifestyle habits to provide information on exercise, dietary recommendations, stress relief, and sleep management to promote overall physical and mental well-being.​