JMDN Generic Name Coding and Route Determination

1. Key takeaways

The smallest administrative unit of Japanese pharmaceutical regulation is the generic name, not the product name chosen by the company. Once the generic name is fixed, four things follow automatically: the risk class, the existence or absence of a certification standard, the filing route, and the body that conducts the quality system investigation. GRZAN lists the determination of the generic name as the first gate of a Japan project because the cost of an error here far exceeds the cost of a translation error: a translation error can be corrected, whereas a coding error forces the project to be restarted from the classification stage onward. The restart is not only a documentation exercise; the route decision, the entity decision, and the evidence plan all inherit the code and must be revisited with it.

• The generic name is the carrier of classification, and every downstream step inherits it.
• Whether certification is available depends on the generic name, not on the maturity of the technology.
• Multi-function combination products converge to one primary generic name, with remaining functions declared as accompanying features.

2. Legal basis

The coding system and its legal anchors are set out below. The designation, the essential requirements, and the certification standards are all expressed at the level of designated items, which is what makes the generic name the operative unit of the entire regime.

1. PMD Act Article 2, Paragraphs 5 through 7: the designation of general, controlled, and highly controlled medical devices is conducted by item.
2. PMD Act Article 41, Paragraph 3: the standards established by the Minister of Health, Labour and Welfare for medical devices (essential requirements).
3. PMD Act Article 42, Paragraph 2: certification standards, being the standards established by the Minister of Health, Labour and Welfare for designated medical devices.
4. PMD Act Article 23-2-13: certification for designated items; Article 23-2-5, Paragraph 1: approval for the remainder.
5. Enforcement Regulations Article 114-8: the designation of the processes subject to the manufacturing business registration, which differs according to the item classification.
6. The medical device generic name search published by PMDA and the certification item listings published by the Ministry of Health, Labour and Welfare are the official search entry points for generic names and the scope of certification.

3. Expert insights

Insight one: the generic name is the carrier of classification, not a translation of the product name.

Each entry of the JMDN, the Japanese medical device nomenclature, contains a generic name, a definition, a code, and a risk classification. When a company translates its Chinese product name literally into Japanese and tries to match it against the entries, it frequently lands on irrelevant entries. The correct method is to search from the intended purpose and the structural principle, and only then to check whether the definition of the candidate entry matches the product. The order matters because the wording of a product name rarely matches the wording of a definition, while the purpose and the structure are what the definition actually describes.

Insight two: the existence of a certification standard is decided by the generic name, not by the company’s technical capability.

Many Chinese companies reason that their products are mature and should therefore qualify for certification. In reality, the feasibility of certification depends entirely on whether the Ministry of Health, Labour and Welfare has established a certification standard for that generic name and has designated it. Technical maturity can only influence the quality of the dossier; it cannot change whether the route is available at all, and treating it as if it could wastes planning cycles. The only question that changes the route is whether the Ministry has spoken on that generic name, and that answer already exists before the company arrives.

Insight three: one physical product may hit several generic names.

Multi-function combination devices often fall within several generic names simultaneously. The Japanese treatment is to determine 1 generic name according to the primary intended purpose, with the remaining functions explained in the dossier as accompanying functions. Where a company files the functions as equals, the reviewers will require convergence at the review stage, and the convergence requested at that late stage is more restrictive than the convergence the company would have chosen itself. Choosing the primary purpose early, with reasons recorded, keeps that choice in the company’s own hands.

4. Practical recommendations

• Adopt the three-step retrieval method of intended purpose, then structural principle, then generic name. Fix the Japanese wording of the intended purpose first, search for entries with similar structural principles, and verify the definition last.
• Have the retrieval result double-checked by two people. Let a regulatory specialist and a Japanese-technical translator search independently; where their conclusions disagree, escalate the matter to a PMDA consultation before submission.
• Write the generic name into a fixed field of the project documents. All later materials, including the application form, the attached documentation, and the quality system materials, should use the same code to avoid inconsistency between documents.
• Confirm certification feasibility on the very day the generic name is fixed. If a standard exists, contact an RCB immediately; if none exists, prepare for approval without waiting in the hope of an exception.
• Re-run the retrieval when the product specification changes. A design change can move the product to a different entry, and the code inherited from the earlier specification then misleads every downstream document.

5. Verification checklist

• □ Was the retrieval sequence led by intended purpose rather than by a literal translation of the product name?
• □ Has the existence of a certification standard under the generic name, and any designation, been confirmed?
• □ Has the combination product been converged to 1 primary generic name?
• □ Is the generic name code recorded as a fixed field in the project documents for later reference?
• □ Has the two-person double check, or a PMDA consultation, been completed?

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