On September 29, 2021, the notification "Handling of Performance Evaluation Tests for Diagnostic Medical Devices Using Existing Medical Image Data, Etc., Involving No Additional Invasion or Intervention (PSEHB/MDED Notification No. 0929-1)" was issued. In connection with this, a "Questions and Answers (Q&A)" administrative communication was issued on December 28, 2022, and a partial revision of that Q&A was issued on March 17, 2025.

Many diagnostic medical devices, such as medical image diagnostic support systems using AI technology and gene mutation analysis systems using DNA sequencers, are currently under development. When a clinical trial (Chiken) is typically required to evaluate clinical efficacy for a pre-market approval application, if existing data can be provided without additional invasion or intervention, the study may be treated as a "performance evaluation test" under this notification. In such cases, a formal clinical trial (Chiken) may become unnecessary, making this a valuable consideration for regulatory strategy.

This guidance applies to diagnostic medical devices such as medical image diagnostic support systems utilizing artificial intelligence technology and gene mutation analysis systems utilizing DNA sequencers.

Eligible Tests:
Tests conducted by collecting existing medical image data, biological samples, and related existing clinical information without any additional invasion or intervention (including the communication of diagnostic results).

Scope of Data:
Limited to data obtained during routine medical care or provided by biobanks and databases (including those operated by private entities).

Waveform Data, etc.:
Video data and waveform information (such as ECG, blood pressure, and EEG) can be handled in the same way as medical image data, provided they do not contain information that clearly identifies an individual.

Based on the content of the test and the necessity of verification against source documents (medical records, etc.), tests are divided into the following two categories as shown in Sections 2(1) and 2(2) of the 0929 Notification. Neither category is classified as a clinical trial (Chiken), and the Medical Device GCP Ordinance does not apply.

【Category (1)】 Collection of Existing Medical Image Data or Biological Samples Only

Content:
Cases where only data or biological samples are collected, and new information necessary for evaluation (e.g., ground truth labels by specialists) is added for use in performance evaluation.

Ensuring Reliability:
Refers to cases where it is not necessary to maintain the ability to cross-check against source documents (medical records, etc.) to ensure the reliability of the data used in the test.

Submission Documents:
Attached to the pre-market approval application as "Documents related to design and development" under Article 114-19, Paragraph 1, Item 1 “Ro” or ロ of the Enforcement Regulations.

【Category (2)】 Collection of Existing Clinical Information (Definitive Diagnosis, etc.) Concurrently

Content:
Cases where existing clinical information related to the data (e.g., definitive diagnosis information used as ground truth) is collected along with the existing medical image data or biological samples.

Ensuring Reliability:
Refers to cases where it is necessary to maintain the ability to cross-check against source documents (medical records, etc.) to ensure the reliability of the clinical information.

Submission Documents:
Attached to the pre-market approval application as "Documents substituting for clinical trial results" under Article 114-19, Paragraph 1, Item 1 “He” or ヘ of the Enforcement Regulations.

Patient Consent and Ethics (For Category (2) in particular):

Principle of Consent:
Appropriate consent from patients for commercial use must be obtained in accordance with the Japanese Act on the Protection of Personal Information and ethical guidelines.

Applicants’ Accountability:
While applicants do not need to directly verify individual consent forms, they must be able to explain the method by which consent was obtained (based on supporting documents such as draft explanation/consent forms and ethics committee review materials).

Consultation with PMDA and Reliability Conformity Assessment:

Pre-sub Consultation:
It is recommended to consult with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding the test protocol and reliability assurance methods before conducting the test.

Reliability Conformity Assessment:
Generally, the management system following data collection will be reviewed. However, if there are doubts about the data (e.g., duplicate use or chronological inconsistencies), a cross-check with source documents (medical records, etc.) may be required.

Application Module for Pre-market Approval Application:
The application module for pre-market approval application depends on the classification of medical device and the applicable category under the 0929 Notification as follows: