Food and drug safety ministry to promote digital device certification at Busan medical fair

The food and drug safety ministry said Thursday it will hold a promotional event for its performance certification scheme for digital medical and health-support devices at a medical equipment exhibition in Busan, aiming to bring small manufacturers into a voluntary regime that took effect in January.

The ministry is running the program with the Korea Information and Communication Technology Association and the Korea AI Medical Healthcare Research Institute at the 14th Busan International Medical Equipment Exhibition, known as 2026 KIMES BUSAN, which opens at BEXCO in Busan on Oct. 23 and runs for three days.

Under the Digital Medical Products Act, the device system has applied since Jan. 24, setting performance standards for products such as heart-rate monitors used in exercise and leisure and operating a certification scheme that companies join at their own discretion. The ministry designates the products covered, which measure biometric signals or provide health-management information to support medical care or maintain and improve health.

The event centers on a policy seminar, promotional booths run by the certification bodies and tailored on-site consulting for interested companies.

At booths B200 and B206 in Halls 2 and 3 of the first exhibition hall, the ministry and the two certifying organizations will introduce themselves and present cases of devices that have already received certification. During the same three days, small and mid-sized companies and startups that have hesitated over certification for lack of information can receive hands-on support with the application process.

"As interest in health-management products using digital technology grows, trust in the products is also important," said Kim Myung-ho, head of the ministry's medical device safety bureau. "We will do our best so that the performance certification system for digital medical and health-support devices can settle in as a system that gives the public peace of mind and gives companies an opportunity to grow."