Samsung Electronics said Friday that key health-tracking features on its Galaxy Watch 8 series have been registered as South Korea’s first “digital medical and health support devices,” under a new regulatory framework for digital health products.
The registration covers core functions of the health management system, including heart rate monitoring, blood oxygen measurement and step counting, the company said.
The designation comes following the introduction of a voluntary reporting and performance certification system from the Ministry of Food and Drug Safety in January, under the Digital Medical Products Act enacted last year.
“Samsung will continue to innovate for preventive health management through wearable devices that are establishing themselves as essential tools for health care,” said Choi Jong-min, executive vice president of Samsung’s digital health team.
The regulatory framework marks the first time Korea has institutionalized oversight of rapidly evolving digital health products, including those using artificial intelligence, beyond traditional medical devices limited to disease diagnosis and treatment.
The ministry said the system aims to increase consumer access by publicly disclosing product information and enabling transparent selection of reliable products free from false or exaggerated advertising.
Samsung Health tracks major indicators such as sleep, activity, diet and mental wellness and provides AI-based personalized insights. The service integrates with Galaxy wearable devices including the Galaxy Watch and Galaxy Ring.
Users can automatically measure their heart rate throughout the day and receive immediate alerts when abnormalities are detected. The devices also enable monitoring of blood oxygen saturation levels during daily activities and sleep to track overall respiratory health, Samsung said.
herim@heraldcorp.com
