Japan Approval Application Dossier: Four-Layer Requirements under the PMD Act

1. Key takeaways

Japan evaluates an approval application around the four-layer requirements set out in Article 23-2-5, Paragraph 2 of the PMD Act (Pharmaceutical and Medical Device Act): eligibility of the applicant → registration of manufacturing sites → quality system in place → quality, efficacy and safety of the product. Many manufacturers treat the submission as a purely technical document package and assume that engineering evidence alone will carry the file. In practice, a deficiency in any of the first three layers will stop the application at formal review, before the technical content is examined at all. GRZAN recommends completing a compliance health check of the entity and site layers first, and only then moving into the preparation of technical documentation.

• The review sequence follows the statutory order of Article 23-2-5, Paragraph 2: corporate eligibility is assessed before any judgment about the product is made.
• The application form is a legally prescribed form, not a format the company may choose freely.
• Approval applications (except those specified by cabinet order) must be submitted through PMDA, the review institution.
• Formal screening and substantive review are separate gates; the first three layers are prerequisites for the technical review to begin.
• Preparation order matters: entity and site compliance first, technical dossier second, with cross-references maintained throughout.

2. Legal basis

The requirements governing the approval application dossier derive from the PMD Act, its implementing rules, and notifications issued by the Ministry of Health, Labour and Welfare (MHLW). The key sources are as follows.

• PMD Act Article 23-2-5, Paragraph 1: approval applications; Paragraph 2: the criteria for review judgment (license of the applicant, registration of the manufacturing site, manufacturing control and quality control, and quality, efficacy and safety).
• PMD Act Article 23-2-5, Paragraph 16: approval applications (except those specified by cabinet order) must be submitted through PMDA.
• Implementing Rules, Form 63-8(1): the application form for manufacturing and marketing approval of medical devices, in the format published by MHLW.
• Notification from the Director-General of the Pharmaceutical and Food Safety Bureau, MHLW, concerning enforcement of the law partially amending the Pharmaceutical Affairs Law and related legislation, Yakushoku hatsu 0806 No. 3, August 6, 2014.
• 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).
• Current statute: Act No. 145 of 1960.

3. Expert insights

Insight 1: The four layers are sequential, not parallel.

The order in which Article 23-2-5, Paragraph 2 lists its requirements mirrors the order of review: eligibility is examined first and the product judgment comes last. This means that even a technically complete dossier will fail if any of the first three layers is missing, because the application will not become viable at the point where review is initiated. GRZAN describes the first three layers as the qualification review layer and the fourth as the technical review layer. Keeping these two layers separate in project planning prevents a common failure mode, in which teams invest months in test reports while the corporate license, site registration, or QMS status remains unresolved. When the qualification layer is confirmed in writing before dossier compilation begins, the technical work proceeds on a stable foundation and rework caused by entity-level defects is avoided.

Insight 2: The application form is a statutory form, not a company-selected format.

Form 63-8(1) of the Implementing Rules and the accompanying notification define the items that must be recorded in the application and the scope of documents to be attached. An application drafted by rewriting a European or American submission template may be returned at formal screening simply because required entries are missing or arranged differently from the prescribed layout. The prescribed form also anchors the attached document set, since the notification referenced above enumerates what must accompany the form. Treating the form and its annex list as a checklist, and filling every entry with a traceable reference, is the most reliable way to pass formal screening on the first attempt. Deviations from the statutory layout, however minor they appear, should be treated as review risks rather than formatting preferences.

Insight 3: The application is filed through PMDA, which defines the intake and communication path.

Article 23-2-5, Paragraph 16 makes clear that approval applications must be submitted through PMDA (except those specified by cabinet order). Companies therefore cannot bypass the institution and lodge files directly with MHLW. All questions, requests for clarification, and corrections during review also occur at the institution level. This has practical consequences for planning: correspondence management, response drafting, and the scheduling of interactions should be organized around PMDA processes and timelines from the outset, rather than improvised after the first query arrives. Recognizing that the institution is the single entry point also explains why submission readiness matters so much: everything passing through this channel is subject to its screening before any technical dialogue begins.

4. Practical recommendations

• Build a self-check table for the qualification review layer. Obtain written confirmation of three items before submission: the category of license held, the registration status of manufacturing sites, and the status of the QMS investigation.
• Prepare the application on the statutory form. Use the MHLW-published form and the accompanying notification as the governing documents; do not reuse application formats from other markets.
• Organize the technical dossier backward from the four layers. First determine which evidence the fourth layer requires, then trace back to the quality system and site documentation that support it.
• Map the annex list to the application entry by entry. Maintain a cross-reference table so that no item cited in the application points to a document missing from the annexes.

5. Verification checklist

• □ Has the self-assessment been completed against all four layers of Article 23-2-5, Paragraph 2?
• □ Does the application use Form 63-8(1) of the Implementing Rules and the format prescribed by the accompanying notification?
• □ Has it been confirmed that the application must be submitted through PMDA?
• □ Does the annex list correspond item by item with the entries in the application form?
• □ Has the scope of attached documents specified in Iyaku hatsu 0331 No. 13 been checked clause by clause?

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