Japan Medical Device Regulatory Map

1. Key takeaways

The skeleton of Japanese medical device market access can be compressed into a single sentence: one law governs the field, four risk classes apply, and three market entry routes exist. What Chinese manufacturers genuinely need to decide in advance is not which document to prepare first, but who will hold the license, which route the product will take, and what the generic name is. None of these three questions can be patched up after the application has been submitted. GRZAN recommends that the first portion of budget and time for a Japan project be invested in generic name confirmation and selection of the license-holding entity, rather than in translation of technical documentation.

• Confirm the Japanese generic name and the assigned risk class before anything else, using official MHLW and PMDA listings.
• Decide the license-holding structure, either a Japanese marketing authorization holder (MAH) or a foreign special approval holder appointing a designated marketing authorization holder (D-MAH).
• Only after these two decisions sequence the dossier work, the certification basis check, and the quality system arrangements.

2. Legal basis

The following instruments constitute the core legal framework referenced throughout this article. Each entry states the instrument, its official number, and the relevant dates, so that internal teams can cite them without re-verifying the source.

1. The Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products, commonly abbreviated as the PMD Act, with the official number Act No. 145 of 1960 (Showa 35).
2. The Act for the Partial Revision of the Pharmaceutical Affairs Law and Other Acts, Act No. 84 of 2013 (Heisei 25), promulgated on November 27, 2013 and effective on November 25, 2014; this act renamed the former Pharmaceutical Affairs Law to its current title and restructured the medical device chapter.
3. PMD Act Article 2, Paragraph 4: the definition of a medical device.
4. PMD Act Article 2, Paragraphs 5 through 7: the classification mandate for general medical devices, controlled medical devices, and highly controlled medical devices.
5. PMD Act Article 23-2-5, Paragraph 1: approval by the Minister of Health, Labour and Welfare; Article 23-2-13: certification by a registered certification body; Article 23-2-12: notification for general medical devices.
6. The Cabinet Order on the effective date, Cabinet Order No. 268 of 2014; the Cabinet Order arranging related cabinet orders, Cabinet Order No. 269 of 2014; and the ministerial ordinance arranging related ministerial ordinances, MHLW Ordinance No. 87 of 2014; all three were promulgated on July 30, 2014.

3. Expert insights

Insight one: the three routes are not fast and slow options but three distinct review logics.

Notification is an administrative filing, certification is a conformity confirmation against an existing standard, and approval is a judgment on the efficacy and safety of an individual product item. The depth of documentation, the reviewing body, and the typical causes of failure differ completely across the three. Preparing an item that requires approval as if it were suitable for certification does not merely cause delay; it renders the entire dossier obsolete and forces it to be rebuilt from the ground up. GRZAN has seen projects lose several cycles to precisely this confusion, which is why the route determination must be treated as a first-order decision rather than a filing detail.

Insight two: the power to classify rests with the Ministry of Health, Labour and Welfare, not with the applicant.

Article 2, Paragraphs 5 through 7 of the PMD Act vest the classification authority in the Minister of Health, Labour and Welfare, and an applicant cannot simply declare its own risk class. The practical method is to first lock the item through its generic name under the JMDN system, then to trace back which class that generic name has been assigned and whether a certification standard exists for it. Skipping this step and directly borrowing FDA or CE classifications is, in GRZAN’s experience on Japan projects, the single most frequent trigger of rework.

Insight three: the renaming of 2014 was a structural change, not a textual one.

Act No. 84 of 2013 removed medical devices from the chapter they had previously shared with drugs, gave devices a chapter of their own, and extended third-party certification from controlled medical devices to certain designated highly controlled medical devices. Understanding this structural shift explains why Class II devices in Japan can go through third-party certification while, within Class III, only those items specifically designated for it may do so. Teams that read the change as a mere renaming tend to misjudge where certification is available.

4. Practical recommendations

• Make generic name retrieval the first step of the project, not product benchmarking. Use the generic name listings published by the Ministry of Health, Labour and Welfare and PMDA to confirm the Japanese generic name and the risk class, and record the confirmation in writing.
• Lock the license-holding entity in parallel as the second step. Where no Japanese corporation exists, compare the route of appointing a local manufacturing and marketing business operator (MAH) against the route of obtaining status as a foreign special approval holder and appointing a designated manufacturing and marketing business operator (D-MAH); the two differ in their consequences for later changes and for replacing the local agent.
• Sequence the documentation third. Only after the generic name and the license-holding entity are settled can the existence of a certification standard, the clinical evidence question, and the body responsible for the quality system investigation be determined.
• Split budget and time according to that order. GRZAN’s experience is that the time consumed by the first two steps should never be compressed; compressing here is equivalent to borrowing from a loan shark against the back end of the project.

5. Verification checklist

• □ Have the Japanese generic name and risk class of the product been confirmed, with the source being a listing published by the Ministry of Health, Labour and Welfare or PMDA?
• □ Has the existence of a certification standard under that generic name been confirmed, thereby determining certification or approval?
• □ Has the type of manufacturing and marketing business license and the form of the license-holding entity (MAH or D-MAH) been confirmed?
• □ Does every cited legal provision carry all four elements (instrument name, official number, promulgation date, and article number)?
• □ Have all lead-time figures in this article been distinguished between official values and practical estimates?

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