Samsung Health has reached a major regulatory milestone, becoming the first platform to receive certification under South Korea’s newly established “Digital Medical and Health Support Device” framework. The recognition marks an important step for digital health services, signalling greater official acceptance of AI-powered wellness platforms alongside traditional medical devices.
The certification was granted by South Korea’s Ministry of Food and Drug Safety under a voluntary registration and performance verification program introduced this year. The system was created as part of the Digital Medical Products Act, which came into force in January last year, and is designed to broaden the definition of medical devices beyond tools used strictly for diagnosis and treatment.
A Shift Toward Digital Health Platforms
Until now, regulatory oversight in South Korea has focused largely on conventional medical equipment. The new framework expands that scope to include digital health solutions that support wellness management, prevention, and lifestyle improvement. Platforms like Samsung Health, which combine wearable data with software analysis and artificial intelligence, now fall within this expanded category.
The certification aims to provide the public with clear and reliable information about registered digital health products. By doing so, regulators hope to reduce the risk of misleading claims and give users greater confidence in the accuracy and purpose of the tools they rely on for health tracking.
Certified Features and Wearable Integration
Samsung registered several core features of Samsung Health during the certification process. These include blood oxygen monitoring, heart rate tracking, and step counting, all delivered through the Galaxy Watch lineup. With approval granted, these features are now the first to be officially recognised under South Korea’s digital medical and health support device system.
Over the years, Samsung Health has evolved from a basic fitness tracker into a comprehensive wellness platform. It now offers users a consolidated view of activity, sleep, and vital signs, along with AI-driven insights to encourage healthier habits.
Implications for Users and the Industry
This certification strengthens Samsung Health’s position as a trusted digital health platform and may influence how similar services are regulated in the future. By setting a precedent under the new legal framework, Samsung is helping define how AI-based wellness tools can coexist with established medical standards.
For users, the move offers added transparency and reassurance that key health metrics provided by Samsung Health meet verified performance criteria. More broadly, it reflects a growing recognition that digital platforms and wearables are becoming integral parts of modern health management.
