Food and drug safety ministry sets review standards for expert-use digital medical software

The food and drug safety ministry issued new guidance Wednesday setting out approval and review standards for digital medical device software that patients use under a clinician's diagnosis, instruction or supervision.

The guideline was established on Sept. 30 by the National Institute of Food and Drug Safety Evaluation, an arm of the ministry. The ministry said it was drawn up under the Digital Medical Products Act to help companies understand the scope of expert-use software, how to fill in an application and what documents are required, and to make approval and review more consistent and transparent.

The document covers how the scope of expert-use software is determined by a manufacturer's intended purpose and the characteristics of the product. It also explains how applicants should describe precautions for both the supervising software and the patient-facing software in an approval application, and what documents are required for a product to be designated as expert-use software.

A checklist is included so developers can confirm whether those precautions, which cover 19 items including the indication, the period of use, risk factors and side effects, are present.

Products covered by the guidance include mobile apps that guide behavioural intervention for children and adolescents through cognitive behavioural therapy on a clinician's instruction, and software that requires precise professional involvement, such as determining doses of medicines that could seriously harm a patient.

The ministry said it plans to keep drawing up approval and review standards so that companies can secure the safety and effectiveness of medical products using new digital technologies and bring digital medical devices to market quickly.

"Through this guidance, we expect to clarify the standards for the safe use of digital medical device software that requires professional judgment and intervention by medical professionals, and to provide practical help to the industry in preparing for product development and approval and review," the ministry said.