MFDS Introduces Voluntary Reporting and Performance Certification System for Digital Medical and Health Support Devices Starting January This Year

Key functions of Samsung Health, installed in Samsung's Galaxy Watch 8 series and others, have been registered as the No. 1 'Digital Medical and Health Support Device' by the Ministry of Food and Drug Safety (MFDS).

The MFDS introduced a voluntary reporting and performance certification system for digital medical and health support devices starting January this year in accordance with the 'Digital Medical Products Act' implemented in January last year. This is the first case of institutionalizing beyond the existing medical device usage scope limited to disease diagnosis and treatment to include rapidly developing digital health products like artificial intelligence (AI).

Through this, the MFDS disclosed information on reported products to the public to increase consumer accessibility and enabled transparent selection and use of accurate and reliable products free from false and exaggerated advertising.

Accordingly, Samsung Electronics actively participated in the MFDS's digital medical and health support device institutionalization movement and completed domestic first registration in the digital medical and health support device reporting system for key Samsung Health functions provided by Galaxy Watch including heart rate, blood oxygen, and step count.

Samsung Health is a health management service that tracks key health indicators including sleep, activity, diet, and mental health and provides AI-based personalized insights, enabling more systematic health management connected with Galaxy wearable devices like Galaxy Watch and Galaxy Ring.

Samsung Health users can automatically measure heart rate all day through Galaxy wearable devices and immediately receive notifications when abnormal signs are detected.

Also, blood oxygen saturation in blood can be measured in daily life to easily monitor overall respiratory health condition, and changes in blood oxygen saturation even during sleep can be confirmed.

Samsung Electronics MX Division Digital Health Team Executive Director Choi Jong-min stated "Samsung Electronics will continue to innovate for preventive health management through wearable devices that are establishing themselves as essential tools for health management."