Japan PMDA Medical Device Approval: MAH, Classes, Certification and QMS Ordinance

Japan is the third-largest medical device market in the world and one of the most rewarding for companies with strong clinical evidence, but it is also one of the most procedure-heavy. The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) run a system with its own classification, its own local legal entity requirement, its own quality system ordinance and, for many files, a Japanese-language dossier. This guide explains how Japanese approval works for a foreign manufacturer, what to prepare first, and where teams most often lose time.

Who regulates what

• MHLW sets the policy and makes the final approval decisions.
• PMDA reviews applications, conducts consultations, audits quality systems and runs post-market safety work.
• Registered certification bodies (RCBs) certify the devices that fall under published certification standards. They play a role similar to a notified body in the EU.

The legal base is the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, usually called the PMD Act, together with ministerial ordinances for quality management, vigilance and labelling.

Classification and route

Japan classifies devices into four risk-based classes, using the Japanese Medical Device Nomenclature (JMDN) to define each generic device type. The class and the existence of a certification standard decide the route.

Class	Risk	Typical route	Who reviews
I	Extremely low	Notification	PMDA (notification only)
II	Low	Certification where a standard exists; otherwise approval	Registered certification body, or PMDA and MHLW
III	Moderate to high	Certification where a standard exists; otherwise approval	Registered certification body, or PMDA and MHLW
IV	High	Approval	PMDA review, MHLW decision

The certification standards, and the list of registered certification bodies, are published mainly in Japanese. Check your JMDN entry first: a device that matches a designated generic name with a certification standard can move much faster than one that needs a full approval review. Our guide to device classification under FDA and EU MDR explains why you should map every market’s class before you build the evidence plan.

The Marketing Authorization Holder

The MAH is the central concept in Japan. It is a Japanese company, licensed for the relevant class of device, that holds the approval or certification and carries legal responsibility for quality, safety information and post-market actions. The MAH must employ a general marketing compliance officer and a safety management supervisor, and it must run quality assurance and vigilance systems under the PMD Act ordinances.

• A foreign manufacturer without a Japanese subsidiary usually appoints an independent MAH (often a consultancy, distributor or a specialist service provider).
• Some foreign manufacturers can hold certain approvals in their own name under a special approval system, but they still need a Japanese representative to act for them.
• The MAH relationship is a long-term commitment. Changing MAH later means transferring the approval and re-establishing the responsibilities, so negotiate access to documents, change control and vigilance duties in the contract from the start.

Registering the foreign manufacturing site

Every foreign site that manufactures the device (including sterilisation and key subassembly sites, depending on the device) must be registered with PMDA before the product can be marketed. The registration identifies the establishment and the categories of work it performs, and it needs to be renewed on the schedule set by the law. Treat it as a gate: if the registration is missing when the approval is ready, the product cannot ship.

Quality management: the QMS Ordinance

Japan requires a quality system that meets the QMS Ordinance (MHLW Ordinance No. 169). It is based on ISO 13485 with additional Japanese requirements, for example on the roles of the MAH, on registration, and on certain records. Compliance is checked through a QMS conformity assessment, either by PMDA or by a registered certification body.

• Japan is one of the five MDSAP regulators. A valid MDSAP audit report covering the right site and scope can be used to support, and often streamline, the QMS assessment.
• Without MDSAP, expect an on-site or document-based assessment, with a longer lead time and more questions.
• The QMS evidence is reviewed per manufacturing site and per product family, so keep your site list and scopes aligned with the application.

Step-by-step for a foreign manufacturer

1. Confirm the JMDN code and the class. Decide whether notification, certification or approval applies, and whether a certification standard exists.
2. Choose and contract the MAH. Cover document access, change notification, vigilance and recall responsibilities, and who pays for what.
3. Register the foreign manufacturing site. Start early because it is on the critical path.
4. Prepare the quality evidence. Line up MDSAP or other QMS evidence and map the QMS to the Japanese ordinance.
5. Build the technical dossier. Use the Japanese application structure. It overlaps with the IMDRF table of contents, but Japan expects its own summaries, including a comparison to existing approved devices where relevant, and Japanese translations of key documents.
6. Decide on clinical evidence. For many new devices, foreign clinical data can be used, but you may be asked to justify applicability to Japanese patients and practice, or to add local data.
7. Use consultations. PMDA offers fee-based consultations before filing. They are valuable for novel devices, for the clinical plan and for the choice of route.
8. File and answer questions. Applications go through the MAH. Expect rounds of questions in Japanese and plan response time for translation.
9. Prepare labelling and launch. Instructions for use, labels and package inserts must be in Japanese, and the device must be coded and identified according to the Japanese labelling and UDI rules.

What you can reuse from FDA and CE evidence

Evidence	Reuse in Japan
ISO 13485 and MDSAP reports	Strong: supports the QMS assessment
Bench and electrical safety testing (IEC 60601)	Strong, if standards and test conditions match. See IEC 60601 safety and EMC
Biocompatibility under ISO 10993	Strong. See biocompatibility
Risk management file (ISO 14971)	Strong
Clinical data from the US or EU	Moderate: depends on device and on the ethnic and practice differences argument
FDA 510(k) or CE certificate	Supporting only: Japan does not accept them as a replacement for its own review

After approval: duties that stay with you

• Vigilance: adverse events and malfunctions are reported through the MAH on the timelines in the Japanese ordinances. Align your global complaint and vigilance process with the Japanese requirements. See post-market surveillance and CAPA and complaint handling.
• Changes: significant changes need a partial change approval or a notification. Build the Japanese impact check into your change control process.
• Re-assessment and renewals: site registrations and QMS conformity assessments have renewal cycles.
• Reimbursement: Japan’s national insurance pricing system is separate from approval and can affect launch timing. Plan it in parallel.

Common mistakes

• Assuming that an FDA clearance or CE mark will shorten the review. It helps the evidence but not the legal route.
• Appointing an MAH late, then discovering it has no experience with the device class.
• Forgetting to register a subcontractor site, such as a sterilisation provider.
• Translating documents at the end rather than writing the dossier so it can be translated cleanly.
• Not checking the certification standard list, and so filing a full approval when a certification route existed.
• Ignoring the vigilance and change control agreement with the MAH until after approval.

Frequently asked questions

Can I sell in Japan without a Japanese company?

No. Every device on the Japanese market needs a licensed MAH, even for a foreign manufacturer. The MAH can be an independent service provider rather than your own subsidiary.

Does Japan accept FDA clearance or a CE certificate?

Not as a substitute for Japanese review. They are useful supporting evidence, and the underlying test and clinical data are often reusable, but the application still goes through notification, certification or approval in Japan.

What is the difference between certification and approval?

Certification is carried out by a registered certification body against published standards, and it is generally faster. Approval is reviewed by PMDA and decided by MHLW, and it is used for devices without a certification standard and for the highest-risk devices.

Do I need Japanese clinical data?

Not always. Foreign data can often be used when you can justify that it applies to Japanese patients and practice. PMDA consultations before filing are the best way to confirm the expectation for your device.

Does MDSAP help in Japan?

Yes. Japan is one of the MDSAP regulators and can use MDSAP audit reports in the QMS conformity assessment, which reduces the need for a separate audit when scope and sites match.

Japanese requirements, fees and timelines change, and many of the original documents are published only in Japanese. Confirm current requirements with PMDA, your MAH and your regulatory advisers before you rely on this guide for a submission.

Related reading

• Global market access beyond the US and EU: how Japan compares with other markets and how to sequence them.
• ISO 13485 and MDSAP audit readiness: the audit program that Japan, the US, Canada, Australia and Brazil share.
• Device classification under FDA and EU MDR: start your class mapping here.
• Regulatory strategy for US and EU market entry: a method you can extend to Asia.
• RAC (Devices) study material: covers PMDA and other global systems.

Talk to the AptSkill team

Planning a Japanese submission or building global regulatory skills? Send us your device type, target markets and goal.