Roles of MHLW, PMDA and Registered Certification Bodies

1. Key takeaways

Administrative authority over medical devices in Japan is distributed: licensing sits with the prefectural governments, scientific review sits with PMDA, approval sits with the Minister of Health, Labour and Welfare, and third-party certification sits with registered certification bodies (RCB). Chinese manufacturers often treat contacting PMDA as the whole story, yet the manufacturing and marketing business license, the manufacturing business registration, and other front-end licenses are issued by prefectural governors, while certification is performed by private organizations. Submitting to the wrong window results in the application being returned unprocessed, so mapping the competent authority for each action is a prerequisite rather than a courtesy. The return is not a rejection on the merits, but the calendar time it consumes is identical, which is what makes the error expensive.

• Prefectural governors issue the manufacturing and marketing business license and the manufacturing business registration.
• PMDA conducts the scientific review; the Minister of Health, Labour and Welfare issues the approval.
• Registered certification bodies, registered by the MHLW, carry out certification and the associated quality system conformity investigation.

2. Legal basis

The allocation of competence among the authorities described above rests on the following provisions of the PMD Act and its enforcement rules. Each entry pairs the procedural action with the competent authority stated in the statute.

1. PMD Act Article 23-2, Paragraph 1: the manufacturing and marketing business license, with the prefectural governor as the licensing authority (exercising affairs delegated by the Minister of Health, Labour and Welfare).
2. PMD Act Article 23-2-3, Paragraph 1: the manufacturing business registration, with the prefectural governor as the competent authority.
3. PMD Act Article 23-2-5, Paragraph 1: approval is granted by the Minister of Health, Labour and Welfare; Article 23-2-7, Paragraph 1 together with Article 37-29 of the Enforcement Order: applications are reviewed through PMDA as the designated institution.
4. PMD Act Article 23-2-13: certification is performed by a registered certification body registered by the Minister of Health, Labour and Welfare.
5. PMD Act Article 23-2-4, Paragraph 1: the registration of foreign manufacturers is executed by the Minister of Health, Labour and Welfare, with application documents submitted to PMDA.
6. PMD Act Article 39, Paragraph 1: the sales and rental business license for highly controlled medical devices (prefectural governor); Article 39-3, Paragraph 1: the sales and rental business notification for controlled medical devices.
7. Corresponding provisions of the Enforcement Regulations: application for the manufacturing and marketing business license, Article 114-2; manufacturing business registration, Article 114-9.

3. Expert insights

Insight one: review and approval are two separate stages, not one.

On the approval route, PMDA performs the scientific review and the Minister of Health, Labour and Welfare issues the approval as an administrative disposition based on the review result. This structure determines that technical communication with reviewers takes place at PMDA, while administrative responsibility and the final decision rest with the Ministry. The addressee of question-and-answer responses, the document letterhead, and the calculation of deadlines must each be handled according to these two stages separately. Conflating the two bodies produces correspondence that neither authority can act on, and it also muddles internal escalation paths when a technical question and an administrative question arrive together.

Insight two: prefectural governments carry most of the business licenses.

The manufacturing and marketing business license, the manufacturing business registration, the sales and rental business licenses and notifications, and the repair business license each fall to prefectural governors or to the competent local health bureau heads. This means that a single project may face 3 or more windows at different administrative levels simultaneously, each with its own fees, review periods, and document formats. A window-by-window comparison table is therefore not optional; it is the only way to keep the parallel tracks coherent.

Insight three: RCBs are private organizations but are supervised through PMDA.

Registered certification bodies are registered by the Minister of Health, Labour and Welfare, and PMDA is responsible for their pre-registration review, their registration renewal review, and their periodic on-site inspections. RCBs are obliged to report the grants and revocations of certifications to the Ministry. Because of this arrangement, an RCB’s certification scope and scheduling can change, so before applying, the project must confirm directly whether that body is still accepting the target item. A confirmation obtained at project planning and never refreshed is worth little; the check should be repeated just before the application is filed.

4. Practical recommendations

• Build a window comparison table. For each matter in the project, list the receiving body, the legal basis, the fee, the document format, and the expected period, so the team stops re-confirming these internally.
• Anchor communication with an RCB at the item level. First confirm whether the body accepts the target generic name, then discuss price and scheduling; a body’s acceptance scope is registered item by item, not by broad category.
• Route approval-track questions through PMDA consultation. Divergences on classification, clinical pathways, and technical requirements are best resolved through the PMDA consultation system before formal submission.
• Put the foreign manufacturer registration on the critical path as a separate item. That registration is executed by the Ministry with documents submitted to PMDA, and it is a shared precondition for both approval and certification, which means that any slip on this item blocks both routes at once rather than only one.

5. Verification checklist

• □ Has the receiving body (MHLW, PMDA, prefecture, or RCB) been confirmed for every matter in this project?
• □ Has it been confirmed that the target RCB currently still accepts certification of the target generic name?
• □ Does the approval-track application explicitly pass through review by PMDA as the institution and approval by the Minister of Health, Labour and Welfare?
• □ Has the destination of the foreign manufacturer registration documents been confirmed as PMDA?
• □ Have fees been calculated separately by receiving body rather than as one combined estimate?

Regulatory 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 manages PMDA submissions across Shonin/Todokede routes, coordinates J-QMS conformity, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com