Choose a PMDA consultation according to the question: general consultation for regulatory systems and consultation options, simple consultation for limited procedural matters, and the appropriate face-to-face advice category for study plans or results.
The key is not simply to describe the product, but to organize "what you want to confirm," "how your company currently views the issue," and "what evidence supports that view" before the consultation.
PMDA consultations provide advice on issues arising during product development, approval application preparation or post-approval changes, within the scope of the selected consultation category.
Examples of topics that may be discussed include:
A consultation is not the approval review itself and does not guarantee approval.
It is important to reflect the advice received in subsequent test plans and application materials.
A free consultation for general regulatory systems and notices unrelated to an individual product, and for identifying which consultation category to use.
It is not a consultation in which PMDA reviews individual product test results or determines whether approval will be granted.
For specific issues related to product development or approval applications, materials are submitted in advance and advice is obtained from PMDA.
Paid consultation categories are available depending on the subject matter. Simple consultation is one of these categories.
Simple consultation is a category of face-to-face advice. The medical device and IVD category covers limited matters, such as the applicable change procedure where this can be determined from appearance, shape, intended use or specifications.
It does not evaluate approval application data. Interpretation of GCP, GLP or GPSP requirements is handled under a separate simple consultation category.
Consultation categories, scope, application procedures, and fees may be revised.
Before applying, check PMDA's latest list of consultation categories and implementation guidelines.
Protocol consultations address study plans; evaluation consultations address completed study results. Examples include:
Organize the intended use, target patients, structure and principle of operation, method of use, and approval and marketing status in Japan and overseas.
Organize the generic name, JMDN code, classification, anticipated regulatory pathway, and comparison with approved devices.
List completed tests, planned tests, clinical evaluation, and the status of application dossier preparation.
For each point to be confirmed with PMDA, align your company's position with the supporting evidence.
When clinical evidence is part of the consultation, define what the available literature and data can support and where uncertainty remains; see the scope of CER preparation support.
Rather than asking only, "Which tests should we conduct?", it is more effective to present your own position, for example:
This makes the issues you want to confirm clearer.
Identify the matters in product development or application preparation for which you want PMDA's view.
Check PMDA's latest guidance to determine the consultation category that corresponds to the issue.
Confirm the prescribed application procedure and submission deadline, then submit the consultation materials.
Explain the consultation questions and your company's position, and identify PMDA's advice and any additional points to be confirmed.
Reflect the consultation outcome in test plans, clinical evaluation, application materials, and the development schedule.
When incorporating the advice into your plan, estimate preparation, testing, and QMS work separately from official fees using the approval timeline and cost guide.
For help planning a consultation or preparing the materials, see Regulatory Strategy & PMDA Consultation Support.
No. It is not mandatory for every product. A consultation may be considered when there is uncertainty about product novelty, required testing, clinical evaluation, or the use of overseas data.
Consulting before the strategy for major tests and application materials is finalized makes it easier to reflect PMDA's advice in the subsequent plan.
Yes. Overseas clinical data can be included in the consultation. The relationship to the intended use and target patient population planned for Japan should be organized in advance.
No. Face-to-face advice does not guarantee approval. During the approval review, the submitted application materials are reviewed separately.
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