Japan Medical Device Regulatory Affairs — PMDA Submissions
Navigating Japan's PMDA regulatory system is straightforward with the right expertise. We specialize in GI endoscopy devices and clinical evaluation-based approvals — helping overseas manufacturers enter the Japanese market with confidence.
Japan Regulatory Affairs
Many overseas manufacturers assume Japan's PMDA approval process is uniquely complex. In reality, with a structured clinical evaluation approach and the right local partner, the path to approval is clear and manageable. We guide you through every step — in English.
Learn MoreServices
We support the full regulatory submission process for Japan (PMDA) — from strategic consulting to complete document preparation. Serving medical device manufacturers seeking Japanese market entry.
Regulatory Affairs Consulting
From PMDA submission strategy and pre-submission consultations to device classification decisions, we provide precise, experience-backed guidance. We make Japan's regulatory requirements clear and actionable, pursuing the fastest path to approval.
Document Preparation Service
We prepare approval applications and all supporting documentation (summaries, design verification & validation records, etc.) on your behalf — accurately and efficiently, fully compliant with PMDA requirements.
Clinical Evaluation Report
We specialize in clinical evaluation-based approvals — no new clinical trials required. From literature reviews to clinical evaluation plans and CER preparation, we deliver end-to-end support grounded in scientific evidence.
Specialty
GI Endoscopy Specialist
Our Strengths
Deep expertise and a clear process — helping your medical devices reach the Japanese market efficiently.
Deep specialized knowledge in gastrointestinal endoscopy devices — endoscope systems, treatment instruments, and related equipment — with thorough understanding of Japan-specific regulatory requirements for this category.
We specialize in obtaining PMDA approvals through clinical evaluation using existing clinical literature and data — no new clinical trials needed. This significantly reduces costs and timelines while ensuring successful approval.
We stay current with the latest PMDA guidance and produce high-quality submission documents quickly, minimizing resubmissions due to deficiencies and enabling smooth regulatory review.
Even manufacturers without a Japan-based regulatory team can rely on us for comprehensive PMDA submission support — from project management to regulatory authority correspondence, handled consistently by our experts.
Message
Japan is one of the world's largest medical device markets — and one of the most rewarding to enter. While PMDA's regulatory framework may appear complex from the outside, the path to approval is well-defined and navigable with the right expertise and strategy.
MK Consulting Co., Ltd. was founded to serve as a trusted local partner for medical device manufacturers — both domestic and international — seeking Japanese market approval. Our deep experience in gastrointestinal endoscopy and clinical evaluation-based submissions allows us to guide clients efficiently through the PMDA process.
In particular, our clinical evaluation approach enables approval without new clinical trials, dramatically reducing development costs and timelines while delivering scientifically grounded results. We tailor our strategy to each client's unique situation and stay at the forefront of regulatory trends.
Entering the Japanese market is an achievable goal. Let us help you get there. Please feel free to reach out at any time.
Representative Director
Kohei Kakuno
MK Consulting Co., Ltd. — Representative Director
Company
Regulatory affairs consulting and document preparation for Japan (PMDA) medical device approvals. Specializing in gastrointestinal endoscopy and clinical evaluation-based submissions.
〒231-0005
4-41 Honcho, Naka-ku, Yokohama, Kanagawa, Japan
5020001152593
Contact
For inquiries regarding Japan regulatory submissions, clinical evaluations, or document preparation, please feel free to contact us. We typically respond within 2–3 business days.