Japan is one of the world's top 10 medical device markets. EU MDR 2017/745 and the PMDA regulatory framework are distinct — but clinical data generated for one can often accelerate the other. This guide explains both frameworks, compares their requirements, and shows how Eclevar MedTech's Tokyo office supports manufacturers navigating both markets simultaneously.
"Japanese manufacturers entering Europe need a partner who understands both PMDA and EU MDR from the inside. Our Tokyo office bridges that gap — in Japanese, from Day 1 of your evidence strategy."
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The first question every Japanese manufacturer asks before entering Europe — and every European manufacturer asks before entering Japan — is the same: how different are the two systems, and can we share clinical data? The answer is more nuanced than a simple yes or no.
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory authority responsible for medical device authorization, subordinate to the Ministry of Health, Labour and Welfare (MHLW). The PMDA was created in 2004 and performs review, inspection, and consultation, while the MHLW regulates the law and issues formal approvals.
| Class | Risk level | Examples | Regulatory pathway |
|---|---|---|---|
| Class I — General | Very low risk even if malfunction occurs | In vitro diagnostics, scalpels, X-ray films | Notification only |
| Class II — Controlled | Relatively low risk if malfunction occurs | MRI, electronic endoscopes, ultrasound diagnostic equipment | Certification / Approval |
| Class III — Specially Controlled | Relatively high risk if malfunction occurs | Dialyzers, ventilators, artificial bones | MHLW Approval |
| Class IV — Specially Controlled | Highly invasive, risk to life if malfunction | Pacemakers, heart valves, stent grafts | MHLW Approval (PMA) |
| Market | Regulator | Number of classes | Key framework | Post-market requirement |
|---|---|---|---|---|
| Japan | PMDA / MHLW | 4 classes (I–IV) | PMD Act · J-GCP · JMDN codes | PMS / Use results surveys (4–10 years) |
| European Union | Notified Body (TUV SUD, BSI) | 4 classes (I, IIa, IIb, III) | EU MDR 2017/745 · ISO 14155:2020 · MDCG | PMCF continuous · Annual PSUR (Class IIb/III) |
| United States | FDA | 3 classes (I–III) | 21 CFR · 510k / PMA · FDA GCP | MDR reporting · Post-market surveillance |
Whether a pre-marketing clinical trial is required in Japan depends on several factors including device novelty, available pre-clinical data, similarity to existing approved devices, and the intended clinical purpose. A PMDA consultation meeting before submission is strongly recommended to clarify the evidence requirements for your specific device.
For devices that are substantially similar to already-approved products, literature data and comparative analysis may be sufficient to demonstrate safety and performance. No pre-marketing clinical trial in Japan is typically required. Foreign data from EU or US studies can support the submission.
For improved devices whose safety and performance have not been sufficiently demonstrated by pre-clinical data and literature data, clinical study data must be submitted. Foreign clinical trials are accepted if conducted to Japanese GCP standards. Post-marketing surveillance will be required to capture Japanese patient data.
For novel medical devices without comparable approved predecessors, comprehensive clinical studies are required to demonstrate safety and efficacy. These may be conducted outside Japan but must comply with J-GCP and address potential differences between Japanese and foreign patient populations through post-marketing surveillance.
Eclevar MedTech has built a complete set of Japanese-language EU MDR guidance pages for manufacturers based in Japan. Each page is signed by Kazuo Watanabe and includes a direct CTA to the Tokyo office.
PMDA governs Japanese approval under the PMD Act. EU MDR 2017/745 governs CE marking via Notified Bodies. Both require clinical evidence but differ in structure: PMDA uses four classes (I–IV) based on JMDN codes and assesses efficacy as well as safety. EU MDR uses Classes I, IIa, IIb, and III and requires continuous post-market clinical follow-up (PMCF) under Annex XIV — a significantly heavier post-market burden than PMDA PMS for high-risk devices.
Yes, in many cases. Clinical data generated for PMDA approval can be included in an EU MDR Clinical Evaluation Report (CER), provided the study was conducted to ISO 14155:2020-equivalent standards and ethnic/population differences are addressed. Around 70% of Japanese device approvals use foreign clinical data. The key is designing the evidence strategy upfront to satisfy both frameworks — not retrofitting after the fact.
No. Pre-marketing clinical trials (Chiken) are not required for all Japanese approvals. Generic or me-too devices can rely on literature data. Improved devices require clinical data only if pre-clinical evidence is insufficient. Novel devices require comprehensive studies. A PMDA pre-submission consultation meeting is strongly recommended to confirm the evidence pathway for your specific device before investing in clinical studies.
Eclevar MedTech's Tokyo office — led by Japan Country Lead Kazuo Watanabe — provides Japanese-language guidance on EU MDR 2017/745 requirements, CER development, PMCF strategy, and clinical data management. Our Paris headquarters team handles all EU regulatory submissions, Notified Body interactions, ethics committee submissions, and in-country CRA monitoring. We serve Japanese clients including Asahi Intecc and Nihon Kohden across cardiovascular, wound care, and orthopedic verticals. Contact us to discuss your corridor strategy.
English and Japanese pages that form the Japan-EU evidence strategy cluster.
Eclevar MedTech's Tokyo and Paris teams design integrated evidence strategies that satisfy both PMDA and EU MDR requirements from a single, well-designed clinical program. First consultation free — in English or Japanese.
