A New Product Class Between Consumer Goods and Medical Devices
Until now, a smartwatch or wellness app was either a medical device or an ordinary consumer product. That changed on January 24, 2026, when the digital health support device provisions of Korea's Digital Medical Products Act took effect and created a category in between.
Intended use is what separates the two regimes. A product that claims to diagnose or treat disease is a medical device and must be approved, certified, or notified. One that stops at health management information is a health support device.
Voluntary Registration — Not Mandatory, but Public
Manufacturers and importers may voluntarily register the product name, intended use, and company details (address, customer support center, website) with the MFDS. Products can still be sold without registration.
The registered information is disclosed to the public, however. Consumers and distributors can look up whether a product is on the MFDS register. According to press reports in late January 2026, key functions of Samsung Health became the first registered case. With large players moving first, registration may well become the market's baseline expectation.
For SMEs, the question to ask is what buyers will require, not what the law requires. Online marketplaces, public procurement, and corporate wellness contracts may all start asking for registration status.
Performance Certification — Who Reviews What
Separately from registration, companies can apply for performance certification of their measurement and analysis functions. Two certification bodies have been designated for a three-year term: the Telecommunications Technology Association (TTA) and the Korea AI Medical Healthcare Research Institute.
What to Prepare
Limits of the Certification Mark
Performance certification is not medical device approval. A certified product still cannot claim diagnostic or therapeutic efficacy. Fees and processing times may differ by body and product type, so confirm them in each certification body's official notice before applying.
False Advertising and Distribution Control — The Risk That Comes First
Registration and certification are optional. Advertising rules are not. Wording that makes a product look like a medical device, and certification claims for uncertified products, are subject to distribution control.
Order matters when adding functions near the medical device line, such as blood pressure, blood glucose, or ECG. Fix the intended use and claims first, then assess whether the function is a medical device, and if it is unclear, ask the MFDS before launch.
A Decision Roadmap for SME Wearable and Health App Makers
Step 4 is decided early in design. Test data gathered for certification can only be reused as clinical evidence if it was collected to a higher standard from the start.
KITIM supports digital health companies with medical device classification reviews, preparation for voluntary registration and performance certification, advertising copy checks, and links to government R&D programs. If you are unsure where your product falls, please contact KITIM for a consultation.