MFDS Issues Approval and Review Guideline for Professional-Use Digital Medical Device Software

The Ministry of Food and Drug Safety (MFDS) issued a guideline on the approval and review criteria for “professional-use digital medical device software” requiring diagnosis or direction and supervision by health care professionals on the 30th.

The National Institute of Food and Drug Safety Evaluation said it issued that day the “Guideline on Approval and Review of Professional-Use Digital Medical Device Software (Guide for Civil Petitioners),” which sets out approval and review criteria for software used by patients under the diagnosis or direction and supervision of health care professionals and other experts.

Professional-use digital medical device software refers to software requiring precise intervention by a health care professional, such as a mobile app that guides behavioral interventions for children and adolescents through cognitive behavioral therapy directed by a health care professional, or software used to determine medication doses that could have fatal effects on patients.

The MFDS prepared the guide to help the industry understand the requirements and improve the consistency and transparency of approvals and reviews by providing detailed guidance on the scope of application under the Digital Medical Products Act, how to complete applications and submission requirements.

The main contents include the scope of application based on the manufacturer’s intent and product characteristics; how to list precautions for supervision software and patient-use software in approval applications; and required submission materials for designation as professional-use software.

The guide also defines 19 types of essential precautions that must be communicated to professionals and patients, including indications, duration of use, risk factors and adverse effects. It also provides a checklist for verifying whether precautions required for direction and supervision software and patient-use software are included.

The MFDS said it expects the guide to clarify standards for the safe use of digital medical device software requiring professional judgment and intervention, providing practical help to the industry in preparing product development and approval and review submissions.

The MFDS plans to continue developing approval and review criteria that reflect the characteristics of medical products incorporating new digital technologies, to ensure safety and efficacy and enable the rapid commercialization of digital medical devices.

More information is available under Laws and Resources on the MFDS website (www.mfds.go.kr).