Procedures for Public Release of Information on Review of Applications for New Medical Devices in Japan

1. Background and Purpose

The Procedures for Public Release of Information on Review of Applications for New Medical Devices (PMDA Notification No. 0206007, February 6, 2009) establishes how information about the review process of new medical device applications is to be released publicly by the Pharmaceuticals and Medical Devices Agency (PMDA) at the request of the Evaluation and Licensing Division, Ministry of Health, Labour and Welfare (MHLW). The procedures aim to make review information available promptly while balancing confidentiality.

2. Submission of Draft Masked Documents

Applicants for new medical device approval must submit draft versions of the masked review report and masked Summary Technical Document (STED) to PMDA within two weeks of receiving a request from the Director of the Office of Medical Devices Evaluation. If both cannot be submitted simultaneously, the draft masked review report should be submitted first.

3. Masking and Adjustment Process

After submission, PMDA reviews the draft masked documents and provides comments. Applicants may raise objections and discuss specific reasons with PMDA staff to adjust the masked documents before public release. Once adjustments are completed, applicants are requested to submit the final electronic test files.

4. Timing of Public Release

The Director Notification encourages applicants to ensure the review report is made public immediately after approval and the masked STED no later than three months after approval. If adjustments are not complete by those dates, PMDA may publish the partially masked report with “Under Adjustment” noted, and later replace it with the final document once adjustments are finished.

5. Masking Principles

When preparing masked documents, information that could identify individuals or harm company interests may be minimized, but key details such as application and approval dates must not be masked. Units, standards, country names where tests were done, and details of clinical studies (with privacy safeguards where required) are generally not to be masked. The applicant must also explain the purpose of public release and ensure consent from information or device providers.

6. Practical Implications for Applicants

These procedures help ensure transparency of the regulatory review process in Japan, enabling stakeholders and the public to access summarized findings and technical details while safeguarding sensitive commercial and personal data. Applicants should prepare masked reports carefully and engage with PMDA on adjustments to facilitate timely public release.

References

• PMDA Notification No. 0206007 — Procedures for Public Release of Information on Review of Applications for New Medical Devices (Provisional Translation, March 2011)