Viv Health announced that the main functions of its self-developed VIV Ring were officially registered on the 5th under the Ministry of Food and Drug Safety‘s ‘digital medical and health support device’ system.
In accordance with the Digital Medical Products Act that came into effect last year, the Ministry of Food and Drug Safety began enforcing enforcement regulations on digital medical and health support devices on January 24 of this year. This goes beyond the medical device-centered management system, which has been limited to the diagnosis and treatment of diseases, and establishes a legal basis to more appropriately support public health management by managing rapidly developing digital health products such as artificial intelligence (AI) within the system.
Previously, on January 30, Samsung Electronics registered major health measurement functions such as heart rate, blood oxygen saturation, and step count of the Samsung Health mobile app as a digital medical and health support device.
Viv Health is the first wearable hardware and smart ring device in Korea to complete registration with the Ministry of Food and Drug Safety. VIV Health’s VIV Ring is a product with the function of measuring and analyzing vital signs and activity data such as heart rate, blood oxygen saturation, and number of steps in the form of a smart ring, and providing health management information based on lifestyle habits records.
This falls under the category of ‘products that measure and analyze biological signals or record and analyze lifestyle habits for the purpose of medical support or maintenance and improvement of health’ defined by the Ministry of Food and Drug Safety.
According to the company, Vibring comprehensively tracks major health indicators such as sleep, activity, stress analysis, heart rate variability, exercise measurement, and sleep-inducing sound functions to improve the sleep environment, and provides personalized health management insights through AI-based analysis.
By simply wearing VivHealth’s smart ring, users can automatically measure vital signs such as heart rate and blood oxygen saturation all day long, and can be notified through notifications when abnormal signs are detected. In addition, when necessary, current biosignals can be checked anytime, anywhere through the real-time measurement function.
Shin Min-young, CEO of Viv Health, said, “Chronic diseases such as obesity, dyslipidemia, diabetes, depression, and sleep disorders are often caused by incorrect lifestyle habits. Viv Health is a wearable device that helps people monitor and improve their lifestyle habits 24 hours a day through a smart ring that anyone can easily wear. We will set a standard that can become a new paradigm in proactive and preventive health care.”
