Last updated: January 30th, 2026 at 11:36 UTC+01:00


Samsung Health clinches first certification as a digital medical device system

A mark of trust.

Adnan Farooqui

Reading time: 2 minutes

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General

Samsung Health has seen a significant improvement in its capabilities over the years. It has evolved into a bona fide health and fitness platform that provides users with a holistic view of their wellness, while also providing AI-powered tips to improve their lifestyle.

The company today announced that Samsung Health has received the first certification under South Korea's Ministry of Food and Drug Safety's “Digital Medical and Health Support Device” system.

It's the first digital medical device system to be certified in South Korea

This is a voluntary registration and performance certification system that was launched by the ministry this year under the country's Digital Medical Products Act, which became law in January last year.

It will expand the scope of medical devices which were previously limited to disease diagnosis and treatment, to include new digital health platforms powered by AI like Samsung Health.

The certification system is meant to provide accurate information about registered products to the public. This will ensure that users have more transparent information about digital medical products and can thus be protected from false or misleading advertising.

Samsung opted for registration of many key Samsung Health features, including blood oxygen, herat rate, and step count, provided through the Galaxy Watch wearable. These are now the first products certified under the digital medical and health support device registration system in South Korea.