eCTD Submission Format for Medical Device Approvals in Japan

1. Key takeaways

Japanese electronic submissions follow the CTD structure, but Module 1 carries a large volume of Japan-specific administrative and regional information, which is the main reason why templates reused directly from European or American dossiers are rejected at formal screening. GRZAN recommends managing submission-format compliance as an independent work package that runs in parallel with technical dossier preparation, rather than performing a format conversion in the final week before submission. Treating format as an afterthought converts a predictable compliance task into an unplanned schedule risk.

• Modules 2 through 5 of the CTD structure are largely internationally harmonized; Module 1 is where the Japanese administrative requirements live.
• Formal screening checks format and completeness; non-conforming submissions are returned without entering technical review.
• Query response deadlines during technical review must be tracked separately (practical estimate: the common response window is 60 days, and extensions can be requested).
• Format and version requirements follow PMDA announcements and must be confirmed on the PMDA website before submission (pending verification until checked).
• The application is filed through PMDA under Article 23-2-5, Paragraph 16 of the PMD Act, except for cases specified by cabinet order.

2. Legal basis

The format requirements for electronic submissions are anchored in the PMD Act, its implementing order and rules, and MHLW notifications, with operational details published by PMDA. The key sources are as follows.

• PMD Act Article 23-2-5, Paragraph 16: approval applications must be submitted through PMDA (except those specified by cabinet order).
• PMD Act Article 23-2-7, Paragraph 1 and Article 37-29 of the Implementing Order: review-related affairs are conducted by the institution.
• Implementing Rules, Form 63-8(1) (application form for manufacturing and marketing approval of medical devices) and the accompanying notification governing attached documents.
• Notification concerning the format of the application for manufacturing and marketing approval of medical devices and the documents to be attached, Iyaku hatsu 0331 No. 13, March 31, 2026 (Reiwa 8).
• PMDA announcements on the intake of electronic applications: format and version requirements follow the latest PMDA announcements (practical estimate: the specific timing of eCTD version transitions must be confirmed on the PMDA website before submission).
• Current statute: Act No. 145 of 1960.

3. Expert insights

Insight 1: Module 1 is Japanized; Modules 2 through 5 are the internationally common part.

Within the CTD structure, Modules 2 through 5 have a high degree of international commonality, while Module 1 carries the application form, administrative information, and region-specific forms. Replacing only the Module 1 pages of a European or American eCTD dossier with Japanese equivalents usually leaves out Japan-specific administrative entries, because the two regions organize administrative content differently. The safe approach is to build Module 1 from the Japanese requirements outward, verifying each prescribed entry against the statutory form and its accompanying notification, rather than adapting a foreign Module 1 inward. teams that plan the module structure this way spend less time reconciling inconsistencies after assembly, and a properly built Japanese Module 1 becomes a reusable asset for the next submission, amortizing the initial effort across products.

Insight 2: Formal screening is an independent gate that occurs before technical review.

Formal screening verifies format and completeness; a submission that fails is returned and does not enter technical review. This means format errors cannot be remedied through subsequent communication with reviewers — the file must be corrected and resubmitted, which consumes calendar time directly. Because the gate is independent, format quality cannot be bought back with strong technical content. A submission that is scientifically sound but formally deficient loses exactly the time that careful format planning would have saved. GRZAN therefore treats the formal self-check as a milestone with its own owner and completion evidence, separate from the technical review-readiness milestone.

Insight 3: Query response deadlines need a ledger of their own.

Queries issued by PMDA during technical review carry response deadlines that must be managed separately (practical estimate: the common response window is 60 days, and an extension can be requested depending on circumstances). Missing a deadline may cause the application to lapse — a risk that in practice outweighs flaws in the technical content itself, since content flaws can be argued while a lapsed deadline cannot. A dedicated ledger that records each query from issuance to closure gives the project team a single view of what is outstanding, what is due, and what has been extended, and it provides the evidence trail needed if an extension becomes necessary. A well-kept ledger also makes handovers between team members safe: whoever picks up an open query can see its full history at a glance, without reconstructing it from correspondence.

4. Practical recommendations

• Set format compliance up as an independent work package. Assign staff familiar with Japanese electronic submission rules and have them work in parallel with the technical documentation team.
• Run one complete formal self-check before submission. Verify the consistency between the application form and the annexes module by module.
• Establish a query ledger. Record four items for every query: the date issued, the deadline, the extension request status, and the date the response was submitted.
• Track PMDA announcements on submission formats. Version and format requirements are updated over time; confirm the current requirements on the PMDA website before submission (practical estimate, not a statutory figure).

5. Verification checklist

• □ Does Module 1 contain the Japan-specific administrative entries, rather than reusing a European or American template?
• □ Has it been confirmed that the application must be submitted through PMDA (Article 23-2-5, Paragraph 16)?
• □ Have the current electronic submission format and version requirements of PMDA been confirmed before submission?
• □ Does the query ledger cover all four items: date issued, deadline, extension status, and response date?
• □ Has the consistency between the application form and the attached documents been verified item by item?

Legal information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team prepares J-GCP/J-QMS compliant dossiers, coordinates conformity assessments, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com