Application for Confirmation of Change Plans for Medical Devices, Medical Devices Utilizing Artificial Intelligence-Related Technologies, and Program Medical Devices in Japan

Overview

Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) have issued detailed Questions and Answers (Q&A) regarding the Application for Confirmation of Change Plans for medical devices, including medical devices utilizing artificial intelligence-related technologies and program medical devices. This administrative notice integrates and revises previous Q&A documents to clarify application methods, document requirements, and handling procedures for confirmations of change plans. (pmda.go.jp) :contentReference[oaicite:0]{index=0}

Purpose of Change Plan Confirmation

The change plan confirmation system (often referred to as IDATEN) is designed to enable manufacturers to obtain confirmation from PMDA that proposed changes to an approved medical device comply with regulations and quality/safety requirements before implementation. These changes may include technical modifications, software updates, or enhancements involving AI-related features or program medical devices. :contentReference[oaicite:1]{index=1}

Key Points in the Guidance

Scope and Eligibility

• Applicants should determine whether a change plan falls under the applicable notification and, if necessary, consult early with PMDA via a predevelopment consultation.
• Predevelopment consultation is recommended particularly for parties with less experience in confirmation submissions, though it may be omitted if the applicant has sufficient prior experience. :contentReference[oaicite:2]{index=2}

Timing of Filing

An application for confirmation of a change plan may be submitted when the information required to support the application is available. If the change plan relates to an approval application already under review, the PMDA reception number for the approval application should be included. :contentReference[oaicite:3]{index=3}

Application Form and Documents

• Applications must include an accurate application form and attachments, prepared according to relevant ministry notifications and adapted to the characteristics of change plan confirmation rather than standard approval applications.
• The number of copies and document format vary depending on the type of device and whether clinical data is included. Online application is permitted, but if requested, certain documents like marketing business licenses may need to be filed. :contentReference[oaicite:4]{index=4}

Attached Documents

• Documents must provide technical justification for the change plan, including reasons for the change and information demonstrating conformity to basic requirements and standards.
• Supplementary documents may include progress tables, comparison tables of before/after changes, test plans and outcomes, and life cycle process summaries for software components. :contentReference[oaicite:5]{index=5}

Q&A

Q: Is a predevelopment consultation mandatory for all change plan applications?
A: No. While recommended to confirm eligibility and improve application completeness, predevelopment consultation may be omitted if the applicant has sufficient experience with confirmation of change plans. :contentReference[oaicite:6]{index=6}

Q: When can a change plan confirmation application be submitted relative to an approval application?
A: If related to an approval application under review, the change plan confirmation application can be submitted once the necessary supporting information is available, using the PMDA reception number assigned at the time of approval application. :contentReference[oaicite:7]{index=7}

Q: Can multiple changes be included in a single application?
A: Yes. Multiple changes may be included but the relationship between each change must be clarified and summarized in the application documents. :contentReference[oaicite:8]{index=8}

Q: Are declarations of conformity required at the time of submission?
A: Declarations of conformity may not need to be attached at the time of submission, but the overview of how conformity will be achieved should be included in the attached documents. Results and final declarations should be attached when submitting notifications related to implementing the change plan. :contentReference[oaicite:9]{index=9}

Practical Advice for Applicants

• Thoroughly plan the contents of the change plan before submission to avoid multiple amendments during confirmation review.
• Use clear labels and progress tables describing each step of change implementation and distinguish them from minor change notifications.
• Ensure all attachments are written in Japanese or are accompanied by Japanese summaries. :contentReference[oaicite:10]{index=10}

Conclusion

This Q&A guidance provides essential clarity to manufacturers and applicants regarding preparation and submission of applications for confirmation of change plans covering standard medical devices, AI-related technologies, and program medical devices. Following the instructions and Q&A helps streamline PMDA review and supports successful confirmation of change plans. :contentReference[oaicite:11]{index=11}