Shonin Approval: PMDA Scientific Review and MHLW Ministerial Decision

1. Key takeaways

Shonin (approval) is the only Japanese pathway that requires an individual judgment of efficacy and safety, and it is structurally two-stage: PMDA conducts the scientific review under Article 23-2-7(1) of the PMD Act and Article 37-29 of the Cabinet Order for Enforcement, while the Minister of Health, Labour and Welfare grants the approval under Article 23-2-5(1). Chinese manufacturers should treat communicating with reviewers and receiving an administrative decision as two distinct work objects on two distinct rhythms.

• Article 23-2-5(1) requires each item to obtain the approval of the Minister of Health, Labour and Welfare.
• Article 23-2-5(2) organizes the grounds for refusal into four layers: licence qualification, registered manufacturing site, manufacturing and quality systems, and the product’s quality, efficacy and safety.
• Article 23-2-5(7) embeds the QMS conformity investigation inside the approval procedure.
• Article 23-2-17 allows a foreign manufacturer to hold the approval itself (foreign special approval); paragraph (5) applies the paragraph (2) refusal grounds but excludes the MAH licence requirement.
• GRZAN’s assessment: most return cycles in this pathway arise in the first three layers of the paragraph (2) checklist, while applicants concentrate their effort on the fourth.
• Because the review institution and the decision maker are distinct, written and oral communication must be addressed to PMDA, while the approval itself arrives as a ministerial act; planning documents should name the two stages separately and never merge them into a single milestone.

2. Legal basis

Approval requirement. Under Article 23-2-5(1) of the PMD Act, items subject to approval must obtain the approval of the Minister of Health, Labour and Welfare. This is the pathway of individual product judgment; neither Todokede (notification) nor certification can substitute for it.

Review-judgment requirements. Article 23-2-5(2) sets out the refusal grounds: whether the applicant holds the corresponding licence, whether the manufacturing site is registered, whether manufacturing management and quality management are in place, and whether the quality, efficacy and safety of the product are recognized. The four layers are cumulative; weakness in any one defeats the application.

QMS conformity investigation. Under Article 23-2-5(7), the QMS conformity investigation is a component of the approval procedure, not a parallel approval. Its scheduling and outcome enter the overall review period directly.

PMDA review. Under Article 23-2-7(1) and Article 37-29 of the Cabinet Order for Enforcement, the approval application is reviewed by PMDA as the review institution.

Foreign special approval. Article 23-2-17 governs foreign special approval holders, meaning foreign manufacturers that hold the approval themselves. Under paragraph (5), the refusal grounds of Article 23-2-5(2) apply mutatis mutandis, except the requirement that the applicant hold a manufacturing and sales licence, since a foreign manufacturer cannot obtain that licence.

Current legal corpus. Act No. 145 of 1960 (the PMD Act).

Practical estimate: the common response window for PMDA inquiries is 60 days, with extensions available on application; tracking should be assigned to a named owner.

3. Expert insights

Paragraph (2) is a four-layer checklist of subject, site, system and product. Article 23-2-5(2) organizes the refusal grounds into four levels: does the applicant hold the corresponding licence, is the manufacturing site registered, are manufacturing management and quality management adequate, and is the quality, efficacy and safety of the product itself recognized. Chinese manufacturers habitually concentrate their energy on the fourth layer, yet returns most often occur in the first three. A written self-check against all four layers before submission is the cheapest insurance available in this pathway.

The QMS conformity investigation is embedded in the approval procedure, not a parallel approval. Article 23-2-5(7) makes the QMS investigation a constituent part of the approval process. Once the application is filed, the investigation’s schedule and result flow directly into the overall timeline and cannot be fully decoupled from the product review. Applicants who plan the product review and treat the investigation as an afterthought routinely see the two tracks collide. GRZAN recommends confirming the investigation schedule with PMDA immediately before and after filing and managing it on the same critical path as the review questions.

A foreign manufacturer can hold the approval itself, with the licence requirement excluded. Paragraph (5) of Article 23-2-17 applies the refusal grounds of Article 23-2-5(2) mutatis mutandis, but excludes the item requiring the applicant to hold a manufacturing and sales licence, because a foreign manufacturer by construction cannot obtain one. This single exclusion is the technical key that makes the foreign special approval system workable. For Chinese manufacturers, holding the approval directly stabilizes ownership: changing a Japanese distribution partner no longer shakes the approval itself.

4. Practical recommendations

• Run the four-layer self-check against Article 23-2-5(2) before submission, with written confirmation that subject, site and system layers are complete.
• Put the QMS conformity investigation on the overall critical path. Confirm the investigation schedule with PMDA or the RCB immediately around the filing date.
• For foreign manufacturers, evaluate holding the approval directly. Article 23-2-17 keeps the approval stable when the Japanese distributor changes.
• Maintain a response deadline ledger for PMDA inquiries, with extension applications tracked (practical estimate: the common response window is 60 days, extendable on application).
• Keep the internal project plan explicit that PMDA review and ministerial approval under Article 23-2-5(1) are two different stages with different owners.

5. Verification checklist

• □ Has the four-layer self-check against Article 23-2-5(2) been completed item by item?
• □ Has the QMS conformity investigation schedule been confirmed in sync with the product review?
• □ For direct holding by a foreign manufacturer, has the exclusion of the licence requirement under Article 23-2-17(5) been confirmed?
• □ Is a deadline ledger with an extension-request workflow in place for PMDA inquiries?
• □ Does the internal plan explicitly separate PMDA review from the ministerial approval decision?

Regulatory information verified as at 29 October 2026. Legal texts follow the current provisions published on e-Gov and the notices issued by MHLW and PMDA, and must be rechecked after amendment or repeal. Time limits and procedural details reflect the official position on that date; content marked practical estimate has no legal effect.

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 premarket submissions and notification procedures, coordinates clinical evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com