The Ministry of Food and Drug Safety (MFDS) recently announced a draft amendment to the Regulation on the Classification and Designation of Digital Medical Products to specify the scope of “Digital Medical/Health Support Devices” as defined under Article 2(4) of the Digital Medical Products Act.

Under the revised regulation, products falling within this category may be voluntarily notified to MFDS and certified for performance starting January 23, 2026. At the same time, MFDS will initiate market surveillance activities in accordance with its distribution and management plan of digital medical/health support devices through collection and inspection of such devices on the market to monitor false or misleading labeling/advertising, etc.

1. Devices for monitoring, measuring, collecting, and analyzing biological signals: Devices that are non-medical devices, used for the purpose of maintaining and improving physical and mental health through measuring, collecting, monitoring and analyzing the following signals:
• Physiological indicators, such as heart (pulse) rate, oxygen saturation, etc. using PPG (PhotoPlethysmoGram) sensors
• Body composition indicators, such as body fat percentage, muscle mass, etc. using BIA (Bioelectrical Impedance Analysis) sensors
• Motion indicators, such as posture, gait, etc. using gyroscopes, accelerometers, etc.
• Mental indicators, such as emotional state, sleep state, etc. using voice or other biometric signals
2. Devices for lifestyle habit recording, analyzing, and providing health management information: Devices that are non-medical devices, used for the purpose of maintaining and improving physical and mental health through analyzing lifestyle habits, etc. to provide the following information:
• Exercise information for physical function improvement
• Dietary information for weight and nutrition management
• Stress relief, sleep management, etc. information for mental health improvement
3. Hybrid products combining both categories above

While products classified as Digital Medical/Health Support Devices are subject to self-regulation through voluntary notification and performance certification, those distributed without such notification or certification will be prioritized for regulatory monitoring. If discrepancies between advertised claims and actual performance are identified, administrative actions, such as business suspension, etc., may be imposed. Therefore, a clear understanding of applicable regulations is essential prior to product development and commercialization.

At MDREX, our team of experts in medical devices, in-vitro diagnostics, and digital healthcare products provides tailored support for regulatory compliance and market strategy. Please feel free to contact us for any questions or further inquiries.