On January 24, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea established the guideline for the approval and review of standalone digital medical device software utilizing usability in accordance with the implementation of the Digital Medical Products Act.
The guideline was created to clearly explain the scope and criteria for usability evaluation when approving or reviewing standalone digital medical device software.
The purpose of this guideline is to provide the criteria for preparing and reviewing the “Approval (Certification) Application” and supporting documents (including the Usability Summary) using the usability engineering files produced through the usability engineering process during approval(certification).
When preparing the digital medical device approval(certification) application, the following must be included (according to Articles 10-21 of the Regulations on Approval, Review, and Disclosure of Digital Medical Products).
1) Shape and Structure
- In accordance with Article 12 (Shape and Structure) of the regulations, the Usability Summary must include <User Interfaces to be Included in the Overall Evaluation>, which should detail menu0driven functions and explanations.
- Information related to safety in the labeling must be included in the Usage Instructions, and Caution, Warning, and Prohibition statements should be listed under Precautions for Use.
2) Performance (Function) or Characteristics
- In accordance with Article 15 (Performance (Function) or Characteristics) of the regulations, the summary must include primary operating functions if applicable.
- These functions must be testable.
- The testing items, standards, and methods for the primary operating functions must be detailed in accordance with Article 19 (Testing Standards) of the regulations.
3) Usage Instructions
- In accordance with Article 17 (Usage Instructions) of the regulations, the summary must include <Use Scenarios Related to Hazardous Factors Subject to Overall Evaluation>
- Information related to safety provided in the labeling must be included in the Usage Instructions.
4) Precautions for Use
- In accordance with Article 18 (Precautions for Use) of the regulations, the summary must include the applied risk controls (such as prohibition, caution, warning statements, etc.) related to the hazardous factors identified in the selected use scenarios for overall evaluation.
- It must also include the prohibited, cautionary, and warning statements related to safety information.
Additionally, the guideline provides instructions on how to prepare the Usability Summary, which can be used as supporting documentation during the approval (certification) application and review process for standalone digital medical device software.
In light of the implementation of the Digital Medical Products Act, companies handling digital medical devices should refer to this guideline when preparing regulatory submission documents.
please refer to the attached document below.
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