Food and drug safety ministry issues AI device certification guide

The food and drug safety ministry said it had issued a guideline for certifying management systems for AI digital medical devices amid rapid technological change.

The guideline was prepared as AI digital medical devices have developed into products based on generative AI, multimodal inputs and outputs, and continuous learning. The program is for companies with strong capabilities in developing, maintaining and managing the safety of AI digital medical devices, with real-world evaluations used to demonstrate product effectiveness.

The criteria cover AI controls, safety management, prevention and response to electronic intrusions, and quality management. They include AI governance involving red teams and clinical experts, information on AI explainability, the designation of a security officer and measures based on a software bill of materials. Applications will be reviewed through document and on-site inspections by a certification committee of internal and external experts.

Certified companies will be regarded as having passed the GMP compliance assessment for digital medical device manufacturing and quality management. During licensing, they may be exempted from submitting some clinical trial evaluation data or use real-world evaluation data instead. Products requiring clinical data must submit a real-world evaluation plan at licensing and a results report within three years.

"The new guideline will allow both the government and companies to respond proactively and flexibly to paradigm shifts in rapidly developing AI digital medical-device technology," Kim Myung-ho, head of medical device safety at the Ministry of Food and Drug Safety, said. "We will continue regulatory support for companies to ensure the certification system operates smoothly."