Telecommunications Technology Association (TTA) said on the 12th that it was designated by the Ministery of Food and Drug Safety as Korea's first agency to conduct performance testing and performance certification for digital medical and health support devices. With this designation, TTA will test and certify the measurement accuracy of digital health products such as wearable devices and health management devices.
The digital medical and health support device performance certification system is based on Article 34 of the Digital Medical Products Act and tests the accuracy of devices that measure biosignals and physiological indicators such as heart rate, oxygen saturation, and body composition, granting certification to products that meet the standards.
TTA, the leading professional institution for ICT standardization and testing and certification, was designated last year by the Ministery of Food and Drug Safety as a regulatory support center for digital medical products (field of preventing and curbing electronic intrusions). With this additional designation, it plans to expand its testing and certification capabilities in digital health while also strengthening its medical device technical support projects.
In addition, to respond to the spread of the AI-based medical industry, in '26 it will expand and reorganize the responsible organization under the AX (AI transformation) and SW (software) research institute into the medical AX unit, and is conducting research and development such as developing evaluation technologies for medical device software and cybersecurity. Alongside this, it will newly offer regulatory support services for corporations, including medical device software conformity assessment (IEC 62304), performance verification, and licensing strategy development.
TTA President Son Seung-hyeon said, "Because digital medical and health support devices are directly linked to public health, securing performance and reliability is more important than anything else," and added, "TTA will contribute to the spread of reliable digital medical products through fair and professional testing and certification services and regulatory support services."