Regulatory Affairs Consulting
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.
Service Overview
Regulatory affairs consulting is the critical first step for medical device manufacturers entering the Japanese market. At MK Consulting, we design the optimal submission pathway tailored to your product's characteristics, risk classification, and market strategy — from PMDA pre-submission meetings through to final approval.
Our Process
Product Analysis & Classification
We analyze your device's intended use, design, and risk profile to determine the correct classification (Class I–IV) and the appropriate certification or approval pathway.
PMDA Pre-Submission Support
We prepare and accompany you through PMDA pre-submission meetings, ensuring your questions are answered and your strategy is validated before submission.
Submission Strategy Design
We design the fastest route to approval, minimizing the scope of required testing and evaluation while ensuring regulatory compliance.
Document Preparation & Submission
We prepare or review your submission documents and support you through the entire submission and review process.
Review Response & Post-Approval
We handle reviewer queries, prepare supplementary materials, and support post-approval change applications.
Why MK Consulting
- Deep expertise and proven track record in GI endoscopy devices
- Up-to-date knowledge of PMDA's latest guidance and review trends
- Unique approach specializing in clinical evaluation-based approvals (no new clinical trials required)
- Comprehensive support for manufacturers with limited in-house regulatory resources
- English support for overseas manufacturers
Frequently Asked Questions
Q. How long does the Japan regulatory approval process take?
A. It varies by product classification and pathway. Certification items typically take 6–12 months; approval items 12–24 months. Pre-submission consultations with PMDA can help shorten the timeline.
Q. Can you handle devices outside of GI endoscopy?
A. Yes. While GI endoscopy is our specialty, we welcome inquiries about other medical device categories. Please feel free to contact us.
Q. Do you work with overseas manufacturers?
A. Yes, we are able to communicate in English. Foreign manufacturers considering entry into the Japanese market are also welcome to contact us.
Related Services
Document Preparation Service
We prepare approval applications and all supporting documentation on your behalf.
詳しく見るClinical Evaluation Report
Clinical evaluation-based approvals — no new clinical trials required.
詳しく見るGI Endoscopy Specialty
Specialized regulatory services for GI endoscopy devices.
詳しく見るReady to Start Your Japan Regulatory Journey?
Start with a free consultation. We'll propose the optimal submission strategy for your product.
Free Consultation