Your first step into the Japanese medical device market.
Understand the regulatory pathway, evidence gaps, key risks and practical next steps before committing significant time and resources to Japan.
Japan Regulatory Assessment
A fixed-fee expert assessment designed to answer one practical question: What will it take to bring your medical device to Japan? The result is a written regulatory roadmap for internal decision-making and the next stage of your Japan project.
Regulatory pathway
- Likely JMDN / generic device name
- Medical device classification
- Notification, certification or approval pathway
- Applicable certification standards, where relevant
- Comparable medical devices in Japan
Evidence & risk
- Testing and documentation gaps
- Clinical evidence considerations
- Potential need for PMDA consultation
- Key regulatory issues and risks
- Indicative timeline and recommended next step
Regulatory difficulty
Low / Medium / High, with the main drivers explained.
Key gaps
What is missing, uncertain or likely to require further work.
Recommended route
A practical recommendation on how to move the Japan project forward.
Start with a clear regulatory roadmap.
Fixed scope and fee confirmed after a free suitability check.
The standard assessment is intended for a single medical device or product family. More complex products—such as novel technologies, SaMD/AI, combination systems, multiple regulatory classifications or substantial clinical questions—may require a broader scope and separate quotation.
The assessment is advisory and does not guarantee a particular regulatory classification, certification, approval or authority decision.
Support can continue through the next stage.
The initial assessment is often only the beginning. Depending on the recommended pathway and project needs, MedEntri Japan can support the regulatory work that follows.
PMDA Consultation Support
Consultation strategy, question development, preparation of briefing materials, meeting preparation and follow-up support.
Certification / Approval Documentation
Preparation and review of Japanese regulatory documentation, including application materials, STED and labeling / IFU-related documentation, as applicable.
Regulatory Authority Responses
Support for technical and regulatory responses to questions raised during certification or approval review.
Japan MAH / DMAH Coordination
For overseas manufacturers without their own Japanese regulatory entity, support can include coordination with or introduction to an appropriate Japan MAH / DMAH service provider, depending on the product and project.
Optional: High-level Reimbursement Review
Where useful, a high-level review of the potential Japanese reimbursement pathway can be added to the regulatory assessment. Detailed reimbursement strategy, health-economic analysis and reimbursement price negotiation are outside the standard assessment and will be scoped separately where specialist support is required.
The initial assessment can be completed without meetings.
Send product information
Share your IFU, brochure, specifications, existing US/EU regulatory status, test data and other available materials.
Written assessment
Once the necessary information is complete, the assessment is normally delivered within 7–10 business days.
Email Q&A
Up to two rounds of email Q&A are included. Follow-on implementation support is quoted separately.
Principal Consultant — Background & Expertise
Over 25 years of experience in the medical device industry, including more than 20 years in regulatory affairs.
After completing a master's degree at Tokyo Institute of Technology, the principal consultant began a career in medical device research and development at a Japanese manufacturer. Subsequent roles at several multinational medical device manufacturers and regulatory consulting organizations covered regulatory strategy, approval and certification submissions, PMDA consultations, and coordination with overseas manufacturers.
In particular, the consultant spent approximately eight and a half years in total in the cardiovascular business of a major US medical device manufacturer. As a regulatory affairs manager, the consultant worked on Class III and IV devices, including approvals for novel medical devices, applications using overseas clinical data, and orphan medical device designation.
The consultant then served for approximately six years as an Associate Director at a global CRO, providing regulatory consulting, PMDA consultation support, and preparation of submission documents for medical device companies in Japan and overseas.
Since becoming independent in 2026, the consultant has supported domestic and international companies with medical device and SaMD regulatory assessments, regulatory strategy, approval and certification submissions, and responses to PMDA and registered certification bodies.
Considering Japan?
Send a brief description of your device, intended use and current regulatory status. We will confirm whether a Japan Regulatory Assessment is a suitable first step.
Request a Free Suitability Checkinfo@medentri.com