Todokede, Ninsho and Shonin: Japan’s Three Market Entry Routes

1. Key takeaways

The three market entry routes in Japan are distinguished by the reviewing body and the object of judgment: notification is filed with PMDA and involves no technical review; certification is a conformity confirmation against existing standards by a registered certification body; and approval is reviewed by PMDA and granted by the Minister of Health, Labour and Welfare, judging the quality, efficacy, and safety of the individual item. The route is determined jointly by the classification and the existence of a certification standard, not by the preference of the company. The cost of a misassigned route is that the whole dossier becomes void, not a mere delay, which is why route selection must follow a fixed analytical order. Every parallel work stream, from evidence generation to entity appointment, hangs off the route, so a route error cascades through all of them at once.

• Notification, certification, and approval differ in reviewing body, object of judgment, and depth of evidence.
• Classification and the existence of a certification standard jointly fix the route.
• The degree to which each route is open to overseas manufacturers differs, and this difference must be built into the holding structure.

2. Legal basis

The three routes and their cross-border variants are anchored in the following provisions. Read together, they show why the routes cannot be chosen freely: each provision states the conditions under which it applies.

1. PMD Act Article 23-2-12: notification for general medical devices.
2. PMD Act Article 23-2-13: designated medical devices must be certified by a registered certification body registered by the Minister of Health, Labour and Welfare.
3. PMD Act Article 23-2-5, Paragraph 1: remaining items require approval by the Minister of Health, Labour and Welfare; Paragraph 2: the elements of the review judgment; Paragraph 7: the quality system conformity investigation.
4. PMD Act Article 41, Paragraph 3: essential requirements; Article 42, Paragraph 2: certification standards.
5. PMD Act Article 23-2-23, Paragraph 1: a foreign manufacturer obtains certification through an appointed Japanese manufacturing and marketing business operator.
6. PMD Act Article 23-2-17: the foreign special approval holder, by which an overseas manufacturer holds an approval itself.
7. The current statute: Act No. 145 of 1960 (Showa 35).

3. Expert insights

Insight one: certification is a conformity confirmation against standards and makes no individual efficacy judgment.

This is the most essential difference between certification and approval. Certification examines whether the product satisfies the published certification standards and the essential requirements; approval examines the quality, efficacy, and safety of the product itself. Under the certification route, therefore, a product that differs markedly from existing items in shape, principle, method of use, or performance cannot be brought under the certification standards and must fall back to approval. Recognizing this boundary early prevents a company from committing to a route that the dossier cannot support, and it prevents the deeper error of weakening a product design to fit a standard when the design itself is the commercial point.

Insight two: a certification application must be accompanied by the quality system conformity investigation.

Under the certification route, the quality system conformity investigation of the manufacturer, including foreign manufacturers, is conducted by the registered certification body. This differs from the approval route, where PMDA conducts it, but the precondition is identical: the relevant manufacturing sites must already have completed the registration as a foreign manufacturer. Scheduling the two lines in parallel from the start is the only way to avoid one finishing long before the other, with the slower line setting the true market entry date regardless of what the plan says.

Insight three: the three routes differ in how far they are open to overseas manufacturers.

Notification can be filed only by a Japanese manufacturing and marketing business operator; certification can be obtained by an overseas manufacturer itself through an appointed Japanese manufacturing and marketing business operator (Article 23-2-23, Paragraph 1); and an approval can be held by an overseas manufacturer itself as a foreign special approval holder (Article 23-2-17). Overseas manufacturers therefore have room to hold approvals themselves for Class II and Class III/IV items, but not for Class I, and this asymmetry should be reflected in the commercial structure chosen. Where self-holding is not available, the drafting of the appointment and change arrangements deserves the same care as the technical dossier, because it determines who owns the authorization when the relationship ends.

4. Practical recommendations

• Fix the judgment order as classification, then existence of a certification standard, then route. Do not select the route first and reverse-engineer the classification to fit it.
• Schedule the quality system investigation in parallel with certification. The certification review by the RCB and the conformity investigation are two parallel lines, and neither certificate can be issued while either remains incomplete.
• Prioritize self-held approval for overseas manufacturers at Class II and above. Holding the approval itself means that changing the Japanese distributor no longer destabilizes the ownership of the approval.
• Treat no standard, therefore approval, as the default rule. Items for which no certification standard has been designated are prepared for approval without exception; do not expect a case-by-case breakthrough, and do not let the hope of one push the classification work to the side.

5. Verification checklist

• □ Has the judgment been completed in the order of classification, existence of a standard, and route?
• □ For items taking the certification route, has the quality system conformity investigation by the registered certification body been arranged in parallel?
• □ Has the overseas manufacturer confirmed whether it can hold the authorization itself on this route (Article 23-2-23 and Article 23-2-17)?
• □ Has the completion of foreign manufacturer registration at all relevant manufacturing sites been confirmed?
• □ Has the wish for speed been excluded as a basis for selecting the route?

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