Clinical Evaluation Report (CER) for Japan PMDA: A Step-by-Step Guide

For overseas medical device manufacturers seeking Japan PMDA approval, the Clinical Evaluation Report (CER) is often the most critical — and most misunderstood — document in the submission package. The good news: for many devices, a well-prepared CER can secure PMDA approval without conducting new clinical trials.

This guide walks you through the CER preparation process step by step.

What is a Clinical Evaluation Report (CER)?

A CER is a systematic review and analysis of clinical data demonstrating that a medical device meets the essential principles of safety and performance. In Japan, the CER is required as part of the approval application submitted to PMDA (Pharmaceuticals and Medical Devices Agency).

The Japanese CER framework is broadly aligned with the EU MDR's clinical evaluation requirements, making it familiar territory for manufacturers who have already obtained CE marking.

When Can You Use a CER Instead of a Clinical Trial?

PMDA accepts clinical evaluation-based submissions (without new clinical trials) when:

• Substantial equivalence can be demonstrated to a predicate device already approved in Japan
• Existing clinical literature provides sufficient evidence of safety and performance
• The device is not a novel, high-risk technology requiring de novo clinical data

This approach is particularly well-suited for:

• GI endoscopy accessories (biopsy forceps, snares, clips)
• Class II and Class III devices with established clinical evidence
• Devices with FDA 510(k) or CE marking and existing clinical data

Step-by-Step CER Preparation Process

Step 1: Clinical Evaluation Plan (CEP)

Before searching for literature, you need a plan. The CEP defines:

• Scope: Which clinical questions will the evaluation address?
• Intended purpose: How is the device intended to be used?
• Acceptance criteria: What level of evidence is sufficient for PMDA?
• Equivalence assessment: How will equivalence to predicate devices be demonstrated?

A well-structured CEP saves significant time during the review phase and helps PMDA reviewers understand your evaluation approach upfront.

Step 2: Literature Search & Screening

Conduct a systematic literature search using:

• PubMed / MEDLINE for peer-reviewed clinical studies
• Cochrane Library for systematic reviews
• Manufacturer's own clinical data (post-market surveillance reports, complaint data)

Apply inclusion/exclusion criteria rigorously and document your search strategy — PMDA reviewers will scrutinize this.

Step 3: Critical Appraisal of Literature

Not all literature is equal. Each included study must be critically appraised for:

• Study design and methodology
• Sample size and statistical power
• Relevance to your device's intended use
• Risk of bias

Step 4: Data Analysis & Evidence Synthesis

Synthesize the appraised data to build a coherent evidence base addressing:

• Safety: Adverse event rates, device-related complications
• Performance: Clinical efficacy, procedure success rates
• Benefit-risk profile: Overall clinical benefit vs. residual risks

Step 5: CER Writing

The final CER must be structured to meet PMDA's requirements, typically including:

Section	Content
Background	Device description, intended use, predicate device comparison
Clinical evaluation scope	CEP summary
Literature review	Search methodology, included/excluded studies
Data analysis	Evidence synthesis, safety and performance conclusions
Benefit-risk assessment	Overall clinical benefit-risk conclusion
Conclusions	Statement of conformity with essential principles

Step 6: Integration into Submission Package

The CER is submitted as part of the overall approval application, alongside:

• STED (Summary Technical Documentation)
• Non-clinical test reports
• Quality management system documentation

Common Mistakes to Avoid

1. Insufficient search strategy documentation: PMDA expects a reproducible, systematic search — not an ad hoc literature review.
2. Ignoring Japanese-language literature: Relevant studies published in Japanese journals should be included.
3. Weak equivalence argumentation: Simply stating a device is "equivalent" without technical justification is insufficient.
4. Outdated literature: PMDA expects the CER to reflect the current state of clinical evidence.

How MK Consulting Can Help

At MK Consulting, CER preparation is our core specialty. We have a proven track record of securing PMDA approvals through clinical evaluation — without new clinical trials — for GI endoscopy devices and other medical devices.

Our CER service includes:

• Clinical Evaluation Plan (CEP) development
• Systematic literature search and critical appraisal
• Data synthesis and benefit-risk assessment
• Full CER preparation in PMDA-compliant format
• Integration into the complete submission package

Contact us for a free CER consultation →