The Ministry of Food and Drug Safety (MFDS) said on Thursday that it published three English guidelines related to digital therapeutics (DTx) and artificial intelligence (AI)-based medical devices.

In particular, the documents include guidance on the review and approval of AI-based medical devices and another on the clinical trial design of AI-based medical devices. It also added a revised edition of the previously published guideline on the review and approval of DTx, first released in November 2020.

These English guidelines were prepared as part of the Bio-Digital Health Commercialization and Regulatory Science Innovation task and were conducted through consults with experts from the Korean Society of Digital Therapy, the Korean Society of Artificial Intelligence in Medicine, and other clinical experts.

Accordingly, the regulations aim to support the overseas expansion of domestic digital medical device companies.

 Additionally, the MFDS plans to share the English guidelines with members of international medical device organizations such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP) to help international organizations recognize Korean regulations. 

Previously, the guidelines for digital therapeutic devices published by MFDS were cited in the International Organization for Standardization (ISO) Technical Report on June 6, 2023, and are referenced by DTx developers worldwide. For example, it was cited in the ISO/TR 11147:2023 Health informatics report on personalized digital health for digital therapeutics health software systems.

The MFDS said that it will continue proactively preparing a legal system for digital medical devices to meet the rapidly changing digital transformation and continuously upgrade the regulatory system for new digital technologies.

“We plan to actively promote the excellence of our regulations wordlwide to aid in the smooth export of domestic digital health technologies,” said an official from the MFDS.