Ministry of Food and Drug Safety Establishes Licensing and Review Standards for Professional Digital Medical Device Software

Includes Guidelines on Stating Manufacturer Intent and Precautions

The Ministry of Food and Drug Safety has established licensing and review standards for professional digital medical device software used by patients under the diagnosis, instruction, or supervision of medical professionals.

Food and Drug Safety Administration in Cheongju, Chungbuk. The Asia Business Daily DB

On September 30, the National Institute of Food and Drug Safety Evaluation, under the Ministry of Food and Drug Safety, announced the enactment of the "Guidelines for the Licensing and Review of Professional Digital Medical Device Software."

Professional digital medical device software refers to software used by patients in accordance with the diagnosis, instruction, or supervision of experts such as medical professionals. Typical examples include mobile applications that induce behavioral interventions in children and adolescents by performing cognitive-behavioral therapy under the direction of a healthcare provider, as well as software that requires precise intervention from healthcare professionals, such as determining the dosage of medicines that can have critical impacts on patients.

This guideline was established to clarify the scope of application, requirements for preparing licensing applications, and submission documentation for professional digital medical device software under the Digital Medical Products Act. The aim is to reduce the burden on related companies as they prepare for licensing, while enhancing the consistency and transparency of the review process.

The guidelines include details on the scope of application based on the manufacturer's intent and product characteristics, as well as instructions on how to specify precautions for both supervision software and patient software in the licensing application.

It also outlines the essential submission documentation and requirements necessary to be designated as professional digital medical device software. In particular, it defines 19 types of mandatory precautions regarding indications, period of application, risk factors, and adverse reactions that must be provided to both professionals and patients, and offers a checklist to confirm whether these items are included in the product.

A Ministry of Food and Drug Safety official stated, "We plan to continuously establish licensing and review standards that reflect the characteristics of medical products utilizing new digital technologies, so as to ensure their safety and efficacy and support the rapid commercialization of such products."

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