The PMDA and EU MDR share more clinical evidence philosophy than any other major frameworks. Our Japan Regulatory Corridor maximizes the value of every clinical data point generated — in both directions.
Pharmaceuticals and Medical Devices Agency.
European Medical Device Regulation.
The PMDA and EU MDR both require prospective clinical data, post-market surveillance, and rigorous benefit-risk analysis. While the documentation structure differs, the underlying evidence philosophy is identical. This alignment creates a structural bridging opportunity that most manufacturers are not currently exploiting to their advantage.
A Japanese manufacturer with PMDA-approved clinical data is not starting from zero for EU MDR. They possess prospective clinical evidence, adverse event coding, and long-term follow-up that directly addresses Annex XIV requirements. The objective is not to determine if data is useful, but to build the bridging architecture so European Notified Bodies accept it without a Major NCR. That is the Japan Corridor.
extracting maximum regulatory value from existing clinical evidence through structured data architecture and population bridging.
Leverage your existing PMDA-approved evidence to eliminate the need for redundant European investigations. We build the bridging analysis required to satisfy Notified Body expectations.
We transform PMDA clinical investigation reports into Annex XIV Part B compliant datasets, demonstrating that Japanese patient outcomes and surgical contexts are representative of EU intended use.
The longitudinal datasets from MHLW Saihenka re-examinations are configured to satisfy EU MDR Class III PMCF requirements, preventing the need for separate European post-market studies.
Device-specific safety data from the PMDA MADAP database is reformatted into MEDDEV 2.7/1 rev.4 evidence grading, providing the robust safety hierarchy needed for your CER.
If gaps remain, we design the minimal bridge study required. By co-designing with PMCF obligations, we close CER gaps and satisfy post-market requirements in a single program.
Support your Shonin application by leveraging EU ISO 14155 investigation data, CER evidence packages, and PMCF outputs to minimise Japan-specific data requirements.
We prepare "Gaikoku Deta" bridging analyses, demonstrating that European ISO 14155 trial data meets J-GCP standards and is applicable to the Japanese clinical context.
We restructure your CER into the specific PMDA dossier format, integrating Japanese State-of-the-Art (SoA) references and required executive summaries for Shonin approval.
Using MILO EDC, we configure your EU PMCF program to simultaneously export MHLW-compliant Saihenka datasets, providing a unified clinical data architecture for both markets.
Where local anatomy or procedural differences require specific data, we design the minimum bridge study necessary, fully integrated with your ongoing European clinical program.
A structured engagement model for both corridor directions. Most programs reach the first regulatory filing within 16–24 weeks of kickoff.
We develop a full catalog of available PMDA clinical data, including Shonin clinical reports, Saihenka submissions, and MADAP safety documentation.
PMDA evidence is mapped against EU MDR requirements. Gaps are classified as addressable via existing data or requiring targeted bridge studies.
We establish J-GCP to ISO 14155 equivalence, analyze patient population representativeness, and perform MEDDEV 2.7/1 quality grading.
A full Clinical Evaluation Report is authored using PMDA data as primary evidence, supplemented by a compliant PMCF Plan.
The CER is submitted with a standalone bridging analysis. We manage the Notified Body questioning to ensure data acceptability.
Assessment of EU investigation data, CERs, and PMCF outputs against PMDA criteria to determine bridging eligibility.
Identification of Japan-specific evidence needs. We define the minimum necessary program before local investment is committed.
The EU CER is reformatted to PMDA Shonin structures, integrating Japanese State-of-the-Art references and labeling compliance.
We design the minimum bridge study required. Data is collected via MILO EDC alongside the ongoing EU PMCF program.
Application filing via licensed representatives. Post-Shonin, the EU program is configured to satisfy MHLW Saihenka requirements.
Real-world evidence architecture. Each case study illustrates a unique clinical bridging strategy between PMDA and EU Notified Bodies.
A structural heart manufacturer used 5 years of PMDA-approved clinical investigation data for their EU MDR CE Mark. Eclevar performed a J-GCP-to-ISO 14155 equivalence analysis, closing a specific bicuspid valve gap with a 60-patient bridge study. No separate PMCF was required.
A spinal implant manufacturer utilized a 1,200-subject EU PMCF registry for PMDA Shonin approval. PMDA accepted the EU data as primary evidence alongside a 120-patient Japan bridge study. MILO EDC exported Saihenka summaries directly from the EU database.
A Japanese vascular manufacturer engaged Eclevar for EU MDR CE Mark. By documenting clinical practice equivalence between Japan and Europe, Eclevar secured 100% data acceptance from the Notified Body without requiring an EU bridge study.
Targeting a shared 24-month window, Eclevar co-designed a single prospective program satisfying both PMDA Saihenka and EU MDR Annex XIV requirements. Clinical data was exported from a shared MILO EDC infrastructure.
"Eclevar understood immediately that our PMDA clinical dossier was an asset in the EU submission process. Their bridging analysis convinced our Notified Body that five years of Japanese TAVI data satisfied Annex XIV."
"EU Notified Bodies do not automatically trust Japanese data. Eclevar translated our PMDA dossier into the language the NB needed to hear. One Q&A round. No Major NCRs. We were surprised at how clean the review was."
"We assumed entering Japan would require building a separate post-market program. Eclevar showed us our EU PMCF registry study was exactly what PMDA needed for Saihenka. Having MILO EDC running both was the key insight."
Managing complex product portfolios for the most exacting global dental manufacturers.
Shofu is a premier Kyoto-based dental manufacturer with an extensive European portfolio covering restorative materials, ceramics, instruments, and CAD/CAM systems. Their EU MDR program requires precise, periodic Clinical Evaluation Reports (CER) for diverse device families.
Periodic CER authoring strictly synchronized with Shofu’s Notified Body submission schedule. We execute comprehensive literature searches and evidence appraisal, calibrated to **EU MDR Annex XIV** and **MEDDEV 2.7/1 Rev 4**.
The **native Japanese fluency** of our Practice Lead allows Shofu’s regulatory teams to communicate directly in their own language. This eliminates translation friction and ensures no technical nuance is lost during critical reviews.
How Eclevar Medtech supports Japanese leaders in managing their complex medical equipment portfolios for global markets.
Nihon Kohden is a recognized global leader in high-precision medical equipment. As part of the compliance transition for their **EEG-1200K system**, Eclevar Medtech provided specialized expertise to transform complex regulatory barriers into a clear, actionable submission strategy.
In-depth support regarding **technical documentation preparation** and guideline mapping. We aligned internal technical datasets with specific European regulatory expectations for diagnostic product families.
**Seamless responsiveness** and total flexibility for direct technical meetings. This agile approach allowed Nihon Kohden teams to proceed efficiently with full confidence in the compliance content.
