CLINICAL EVALUATION
A Clinical Evaluation Report (CER) evaluates literature and clinical data to explain a device’s safety and effectiveness. MK Consulting K.K. supports the evaluation approach, review or revision of existing CERs, and report preparation for the proposed Japanese application.
Not every Japanese application requires a CER. The need and scope depend on the product characteristics, application pathway, differences from approved devices and available evidence.
Teams planning clinical evaluation, adapting an overseas CER for Japan or responding to PMDA questions.
We review your product and the documents you have, then agree with you on the tasks we will undertake.
We assess the evidence for safety and effectiveness against the intended use, target patients, product characteristics and differences from approved devices in the Japanese application. Existing overseas CERs are also checked against the proposed Japanese application.
Director Masaaki Hitomi previously worked at Century Medical, Inc., where he handled approvals using clinical trial data generated overseas and approval applications using CERs based on the review and assessment of existing literature.
Based on the intended use in Japan, target patients, product characteristics and differences from approved devices, we identify the safety and effectiveness matters to be explained in the clinical evaluation and the evidence supporting them.
We prepare a plan specifying the evaluation scope, literature search methods, inclusion and exclusion criteria, and evaluation endpoints.
We document how literature, overseas clinical data, existing test results and post-market information can support the Japanese application, including limitations and the basis for each assessment.
We prepare a CER explaining what has been established about safety and effectiveness and what remains unknown, with the supporting evidence for each. We also check consistency with the application dossier as a whole.
CASE STUDIES
Client names and product details remain confidential. Each case distinguishes the work performed from the confirmed outcome.
CER revision and response drafts completed
Case study of CER review and PMDA inquiry support for a medical device application in Japan, including evidence gaps and response preparation.
This engagement delivered a revised CER and draft responses; obtaining product approval was not included in its scope.
The client provides product information, overseas regulatory status, existing documents and authority consultation records. MK Consulting identifies missing materials and questions to address; both parties agree the deliverables and responsibilities.
MK Consulting proposes the evaluation and search plan, and aligns the Japanese application scope with the client. We then conduct the agreed search and appraisal, prepare drafts and ask the client for additional information where needed.
The client checks product information and application content in the drafts; MK Consulting incorporates the comments. We resolve inconsistencies with the application form, STED, risk management and statutory labeling, and identify unresolved matters in the completed reports.
We assess the relevance of similar-device or previous-model data to the Japanese application, considering technical, biological and clinical similarities and differences. We identify gaps in the available evidence and matters that may need additional explanation, data or PMDA consultation.
When PMDA asks for clarification, we review the inquiry against the existing CER and supporting materials, organize evidence gaps, and prepare draft responses and corresponding report revisions. We review the questions and available documents and agree with you on the tasks we will undertake.
The evidence strategy and deliverables require a project-specific assessment. Existing literature or an overseas CER may support the application, but cannot be assumed to cover every Japanese requirement or replace additional clinical data where needed.
Not necessarily. We review the intended purpose, target patients, product specifications, and comparison with approved devices in the Japanese application and consider whether the CER can support the content of that application.
Yes. We review the novelty of the product, differences from existing devices, and available literature and clinical data, then consider whether a CER is needed for the Japanese application and what evaluation to conduct.
We review existing nonclinical tests, literature, overseas clinical data, and other information and organize which issues may be explained by existing data. Where appropriate, we also identify matters to confirm through PMDA consultation.
Share your product overview, whether a CER or clinical data is available, and the work you need.
Discuss Your CER Requirements