The Korea Artificial Intelligence (AI) Healthcare Research Institute announced on Wednesday that it has been designated by the Ministry of Food and Drug Safety as an authorized agency for performance testing and certification of digital medical and health support devices.
This certification system operates under Articles 34 and 48 of the Digital Medical Products Act,which aims to regulate and standardize digital health technologies.
The system evaluates the accuracy of digital health devices designed for health management and grants performance certifications to products meeting stringent standards.
This designation marks a significant milestone for the institute, which recently upgraded from the Korea Smart Medical Device Industry Promotion Foundation to a specialized production technology research institute, rebranding itself as the Korea AI Healthcare Research Institute.
Since its inception, the institute has been a pillar of support for the medical device industry, focusing on research and development, standardization, and rigorous testing. This new designation expands its role, positioning it as a specialized research institution capable of conducting comprehensive testing, validation, and certification of digital health devices.
Looking ahead, the institute plans to bolster its testing and validation infrastructure for digital health and wellness products, with a particular focus on wearable devices. By strengthening industry support, it aims to foster a trust-based ecosystem in the digital health sector and enhance the competitive edge of corporate products.
Dr. Lee Se-hwan, Director of the institute, emphasized the significance of this achievement, stating that this designation as a performance certification agency is a testament to the growth since becoming a specialized production technology research institute. They’re committed to further developing the capabilities in testing, validation, and certification within the digital health and wellness device sector. The ultimate goal is to drive industry advancement and contribute meaningfully to public health improvement.