MFDS streamlines digital medical device approvals

Rules governing approval, certification, notification and review of digital medical products revised

Clinical data submission and exemption criteria clarified based on real-world cases

The Ministry of Food and Drug Safety (MFDS) (Commissioner: Yu-kyoung Oh) will clarify the standards for requiring clinical trial data in digital medical device approvals and broaden eligibility for special treatment under certified quality management systems.

On the 27th, the MFDS revised its ‘Regulation governing the approval, certification, notification, review and assessment of digital medical products.’

The revision was pursued as part of the ‘2026 Food and Drug Safety Initiatives,’ which were selected through direct communication with the public and consideration of needs identified in the field. It is intended to address difficulties experienced by companies during the approval process.

Since the Digital Medical Products Act took effect in January last year, software-based digital medical devices have, in principle, been required to submit data including clinical trial results when applying for approval. However, applicants may omit such data or submit alternative data when they provide supporting grounds for an exemption and receive recognition from the MFDS commissioner.

The MFDS analyzed the approval and review status of approximately 1,000 digital medical device software products authorized to date. Based on actual cases in which approval was granted using performance validation data without clinical trial data, it established more specific criteria for the submission and exemption of clinical evidence.

In addition, considering the rapid pace of advancement in artificial intelligence technology, the scope of application for the certified quality management systems special exemptions will be expanded from the current Class II to unclassified targets. The period for granting actual-use special exemptions will be extended from a range of 1 year to up to 3 years.

Myung-ho Kim, Director-general of the Medical Device Safety Bureau at MFDS, said, “This revision is expected to improve regulatory predictability, reduce unnecessary clinical trials and promote the development of products based on the latest AI technologies. We will soon issue detailed guidelines on quality management system certification and continue supporting the growth of Korea’s medical AI sector.”