Handling Performance Evaluation Tests of Diagnostic Medical Devices Using Existing Medical Image Data Without Additional Invasion/Intervention in Japan

Overview

Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued Notification No. 0929-1 regarding how performance evaluation tests for diagnostic medical devices can be handled when they are conducted using existing medical image data or biological samples without additional invasive procedures. This guidance clarifies that such studies, under specific conditions, do not constitute clinical trials under Japanese regulations and may be used as an attachment for marketing approval applications. :contentReference[oaicite:0]{index=0}

This handling particularly applies to diagnostic devices like AI-powered medical imaging support systems or gene mutation analysis systems that rely on image data collected in routine medical care or from biobanks and databases. :contentReference[oaicite:1]{index=1}

Key Provisions

1. Scope of Applicable Performance Evaluation Tests

This handling applies to performance evaluations that collect:

• Existing medical image data or biological samples.
• Existing information on diagnosis and treatment related to such data.
  The data must originate from routine medical care or existing repositories (biobanks, databases), and must not be collected under invasive clinical research. :contentReference[oaicite:2]{index=2}

2. Non-clinical Trial Classification

When only existing data or samples are used and no verification against original documentation (like medical records) is needed to ensure data reliability, then:

• The performance evaluation test does not constitute a clinical trial under the Medical Device GCP Ordinance.
• Therefore, requirements that apply to interventional clinical trials do not apply to these studies.
• Applicants must still implement appropriate quality assurance/quality control (QC/QA) measures to ensure data reliability.
• The resulting documents should be attached to the marketing approval application as part of the design and development documentation. :contentReference[oaicite:3]{index=3}

3. Cases Involving Diagnostic Information

When the evaluation involves existing image data and related diagnostic information (for example, confirmed diagnoses used as correct answers) and it is necessary to verify the reliability of the information using original documentation:

• The test still does not constitute a clinical trial.
• However, ethical and legal considerations apply, including compliance with:
  • The Act on the Protection of Personal Information;
  • The Ethical Guidelines for Life Science and Medical Research Involving Human Subjects;
  • Robust QC/QA mechanisms for data control and reliability.
• Documentation must be prepared to demonstrate appropriate handling and reliability controls.
• These materials can substitute for clinical study results in the attached data of the marketing approval application form. :contentReference[oaicite:4]{index=4}

4. Other Considerations

Before conducting performance evaluation tests under this handling, applicants are encouraged to consult with the PMDA regarding the study protocol and methods for ensuring data reliability. Whether the device evaluation can rely solely on such existing data will be judged on a case-by-case basis. :contentReference[oaicite:5]{index=5}

Q&A

Q: What kinds of data are covered under this handling?
A: Existing medical image data, biological samples, and associated diagnostic/treatment information collected during routine medical care or from databases and biobanks, provided no additional invasive procedures are performed. :contentReference[oaicite:6]{index=6}

Q: Does using existing data always mean the study is not a clinical trial?
A: If only existing data or samples are used without requiring verification with original records for reliability, the performance test does not constitute a clinical trial under the Medical Device GCP Ordinance. However, appropriate QC/QA must still be in place. :contentReference[oaicite:7]{index=7}

Q: Are there ethical requirements when using diagnostic information?
A: Yes. When diagnostic or treatment information is included and verification against original records is needed, applicants must comply with personal data protection and ethical guidelines (such as the Act on the Protection of Personal Information and Ethical Guidelines for Life Science and Medical Research). :contentReference[oaicite:8]{index=8}

Q: How should the results be submitted?
A: The documentation from these tests should be attached to the marketing approval application as part of design and development materials indicated for performance and safety evaluation. :contentReference[oaicite:9]{index=9}

Practical Tips for Applicants

• Conduct a pre-submission consultation with the PMDA to confirm that the performance evaluation plan meets the criteria for handling under this notification.
• Document QC/QA systems clearly to demonstrate control and reliability of the data used.
• Ensure all ethical and privacy requirements are addressed before attaching data to the application. :contentReference[oaicite:10]{index=10}

Conclusion

Japan’s handling of performance evaluation tests using existing medical image data without additional intervention provides a framework for using retrospective, non-interventional data in regulatory submissions. By clarifying that such tests are not clinical trials under certain conditions, this notification supports efficient evaluation of diagnostic devices, including those leveraging advanced technologies like AI. :contentReference[oaicite:11]{index=11}