REGULATORY STRATEGY
We organize the regulatory issues for a device before its Japanese application pathway or required evaluations have been determined. For products under development or already marketed outside Japan, we clarify what must be checked before application documents are prepared and how the work should proceed.
Unsure whether your product is a medical device? See where to ask and how to check.
We support development and regulatory teams defining a Japan application pathway, including overseas manufacturers planning market entry. You can consult us before starting new tests.
Not all product information needs to be complete. We distinguish what is currently known from what still requires confirmation.
Based on your product and available documents, we agree with you on the work needed and our responsibilities.
We review the intended purpose, target patients, structure and principle, method of use, and conditions of patient contact. We investigate the Japanese generic device name, JMDN code, classification, and the existence and scope of any certification standard, then organize the likely pathway and the basis for that assessment.
We identify similarities and differences from approved or certified devices and clarify what must be explained for performance, safety, and clinical evaluation. If a marketing approval application is anticipated, we also consider whether the application may be treated as a new, improved, or generic medical device in Japan.
We review technical documentation, test reports, and Clinical Evaluation Reports (CERs) prepared outside Japan. We compare them with the intended purpose and specifications planned for Japan and distinguish matters that can be explained with existing documents from matters requiring additional evaluation.
For each issue to be confirmed, we compile your position and supporting documents. We consider the appropriate consultation body, consultation category, and timing, support preparation of the consultation materials, and help reflect the resulting advice in the development and application plan.
The appropriate PMDA consultation category depends on the subject of the consultation.
We support medical devices broadly and review application issues from both the product specifications and actual method of use. We also draw on experience in GI endoscopy and biliary-pancreatic devices when considering how differences from existing products may affect the evaluation approach.
MK Consulting does not decide whether approval or certification will be granted. We organize the necessary evidence and confirmation points and support consultation with the relevant authority or body and preparation for the application.
We ask about your product, development stage, approval status in Japan and other countries, and current concerns to clarify the purpose of the consultation.
We review the Japanese generic device name, certification standards, existing devices, and available data, then list matters requiring a decision when considering the application strategy.
We separate additional evaluations that may be needed from questions to be confirmed with the relevant authority or body. If a consultation will be held, we prepare materials that link each question to its supporting rationale.
Based on the review and any advice received, we organize the approach for testing, clinical evaluation, and preparation of application documents.
We explain which tests and documents are needed, who will prepare them, and what needs to be decided before submission.
Items not yet confirmed are distinguished from established facts. We also identify where the strategy may change after consultation or additional data, so the result can support the next decision.
The following page explains support for preparing application forms and technical documents, submission preparation, and responses to review questions after the application strategy has been determined.
Yes. Based on the proposed specifications and intended purpose, we propose which matters should be decided now and which can be confirmed as development progresses.
Yes. You can discuss the scope needed, from organizing consultation questions, your position, and supporting documents to considering the strategy after the consultation.
Yes. Along with the regulatory strategy, we consider the structure needed for entry into Japan and specify the responsibilities of the Japanese parties. MK Consulting does not itself act as the Designated Marketing Authorization Holder (DMAH), but can support coordination with potential candidates when needed.
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.
Share your product overview, current development stage, and questions about the proposed application.
Contact us about regulatory strategy and PMDA consultation