MFDS Establishes Guidelines for Performance Evaluation of Digital Medical Device Components

The Ministry of Food and Drug Safety (MFDS) has established guidelines for evaluating the performance of digital medical device components.

The National Institute of Food and Drug Safety Evaluation, an agency under the MFDS, said on the 16th that it had established the guidelines to support implementation of the performance evaluation system for digital medical device components, newly introduced under the Digital Medical Products Act, and to improve industry understanding of the system.

Components are parts with independent functions that affect the performance of digital medical devices. They include sensors that measure biosignals and other data (including related software) and AI-based programs that perform medical functions.

Under the performance evaluation system, the MFDS evaluates in advance the performance of AI algorithms, sensors and other components responsible for the core functions of digital medical devices. Manufacturers can apply for approval or authorization of a digital medical device using components that have completed the pre-evaluation.

To make the guidelines effective and practical, the MFDS gathered feedback from the field through a consultative group of experts, including manufacturers, importers and testing and inspection agencies, and incorporated the results.

The guidelines cover the background and purpose of the component performance evaluation system; criteria and examples for determining whether a component is subject to evaluation; application procedures; and instructions and specific examples for completing application forms and preparing supporting documents.

The MFDS said it expects the guidelines to provide clear direction to applicants and help the industry reduce development costs and shorten the time to commercialization. It plans to continue publishing guidelines to support faster market entry for digital medical devices.

The full guidelines are available on the MFDS website (www.mfds.go.kr) under “Laws and Materials → Legal Information → Guidance for Public Officials/Guidance for Applicants.”