Regulatory Approval Support
Regulatory Approval Support
All medical devices sold in Japan require approval or certification from the regulatory authority (PMDA/MHLW) under the Pharmaceutical and Medical Device Act. MK Consulting provides end-to-end support — from submission document preparation to review response.
Service Overview
Every medical device sold in Japan must obtain approval or certification under the Pharmaceutical and Medical Device Act (PMD Act). Submission documents must scientifically demonstrate the device's efficacy, safety, and quality through product descriptions, development history, non-clinical and clinical data, biocompatibility, and manufacturing quality control. For devices developed overseas, MK Consulting integrates manufacturer data with Japan-specific regulatory requirements to prepare optimal submission packages.
Device Classification & Submission Categories
| Class | Risk Level | Submission Type | Review Body |
|---|---|---|---|
| Class I | Low Risk | Notification (Self-certification) | Prefecture |
| Class II | Moderate Risk | Third-party certification or Approval | Registered Certification Body / PMDA |
| Class III | Moderate–High Risk | Approval or Certification* | PMDA |
| Class IV | High Risk | Approval | PMDA |
* Certification applies only to designated controlled medical devices
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 submission pathway (notification, certification, or approval).
Submission Strategy Development
We integrate manufacturer data, test results, and Japan-specific regulatory requirements to develop the fastest path to approval. We also support PMDA pre-submission consultations.
Document Preparation
We prepare or review approval applications and attachments (summary documents, test reports, clinical evaluation reports, etc.). English support for overseas manufacturers is available.
QMS Conformity Assessment Support
We support the QMS (Quality Management System) conformity assessment required in parallel with the manufacturing and marketing approval application.
Submission & Review Response
We manage document submission and handle reviewer queries and supplementary material preparation throughout the review process.
Post-Approval Support
We support partial change approvals, minor change notifications, and ongoing regulatory management throughout your product's lifecycle.
Why MK Consulting
Proven track record in GI endoscopy device approvals
Up-to-date knowledge of PMDA guidance and review trends
Specialized in clinical evaluation-based approvals (no new clinical trials required)
English support for overseas manufacturers (document translation, communication)
Comprehensive outsourcing support for manufacturers with limited regulatory resources
One-stop service from application to post-approval management
FAQ
Q1How long does the regulatory approval process take in Japan?
It depends on the device classification. Third-party certification typically takes 6–12 months; approval pathways typically take 12–24 months. PMDA pre-submission consultations can help shorten the timeline.
Q2Our device already has FDA/CE approval. Do we still need Japanese approval?
Yes, Japan requires its own approval or certification under the PMD Act. However, existing FDA or CE approval data can often be leveraged to streamline the Japanese submission.
Q3Can you handle devices outside the GI endoscopy field?
Yes. While GI endoscopy is our specialty, we handle a wide range of medical devices. Please feel free to contact us.
Q4Can we engage you for strategy development as well as document preparation?
Absolutely. We provide end-to-end support from product analysis and classification through strategy development, document preparation, and review response. Partial engagements are also welcome.
Consult Us About Your Regulatory Approval
Start with a free consultation. We'll propose the optimal submission strategy for your product.