PMDA Face-to-Face Consultation Utilization Guide: Explaining Types, Application Methods, and Fees

PMDA face-to-face consultation is an extremely important system that allows direct acquisition of official views from the regulatory authority during the development and application process of medical devices. Whether or not to utilize face-to-face consultation before submitting an approval application significantly impacts the review period, required additional data, and the amount of rework. This article explains the types of face-to-face consultations, how to choose them, application methods, and tips for effective utilization, including points that require particular attention.

<h2>Table of Contents</h2> <ol> <li><a href="#heading-0">What is PMDA Face-to-Face Consultation: Positioning of the System</a></li> <li><a href="#heading-1">Types of Face-to-Face Consultations: Overview of Consultation Categories</a></li> <li><a href="#heading-2">How to Use Each Consultation Category</a></li> <li><a href="#heading-3">Application Method and Flow to Implementation</a></li> <li><a href="#heading-4">Documents to Prepare</a></li> <li><a href="#heading-5">Overview of Fees</a></li> <li><a href="#heading-6">Tips for Maximizing Face-to-Face Consultation</a></li> <li><a href="#heading-7">Points for Overseas Manufacturers to Pay Special Attention To</a></li> <li><a href="#heading-8">Summary</a></li> </ol> <hr> <h2>1. What is PMDA Face-to-Face Consultation: Positioning of the System</h2>

Face-to-face consultation is a system where manufacturers, marketing authorization holders, academia, etc., engaged in the development of medical devices and in vitro diagnostic medical devices, directly interact with PMDA staff to obtain official advice on development plans and application contents. The biggest feature is the ability for two-way discussion, unlike written responses.

Records of advice obtained through face-to-face consultation are referenced by PMDA as a shared understanding with the applicant during the subsequent approval application review. This means that, in principle, PMDA will not overturn agreements made during face-to-face consultation, which significantly enhances the predictability of obtaining approval for the applicant.

Face-to-face consultation is utilized in the following situations:

<ul> <li>Confirmation of the validity of development plans (e.g., class classification, application category, scope of required tests)</li> <li>Preliminary alignment on the structure and content of application documents</li> <li>Confirmation of whether existing data can be utilized for approval applications in Japan</li> <li>Advice on the content of Clinical Evaluation Reports (CER)</li> <li>Confirmation of response strategies for inquiries during review</li> </ul> <hr> <h2>2. Types of Face-to-Face Consultations: Overview of Consultation Categories</h2>

Face-to-face consultations for medical devices and in vitro diagnostic medical devices are divided into multiple consultation categories, which are used depending on the development phase and consultation content. The main categories are as follows:

<h3>General Medical Device Consultation</h3>

Addresses general questions at the early development stage. You can confirm class classification applicability, determination of application category, presence of certification standards, and an outline of necessary tests. This is a relatively light consultation and serves as the initial point of contact.

<h3>Medical Device Pre-Development Consultation</h3>

A consultation to confirm the overall validity of the development plan before commencing full-scale development. It involves sharing the scope of non-clinical trials, the necessity of clinical evaluation, and the direction of the development strategy with PMDA.

<h3>Medical Device Pre-Submission Consultation</h3>

A consultation conducted just before submitting an approval application to make final confirmations on the content and structure of the application documents. It is utilized to minimize rework after the application is accepted.

<h3>Medical Device Protocol Consultation</h3>

A consultation to receive specific advice from PMDA on the content of the clinical trial protocol (clinical trial implementation plan). This is an almost essential step when conducting clinical trials.

<h3>Medical Device Evaluation Consultation</h3>

A consultation to receive advice on the evaluation methods for clinical trial data and non-clinical data, and how to incorporate them into application documents.

<h3>Medical Device Reliability Standards Conformity Consultation</h3>

A consultation to confirm whether application documents conform to reliability standards (GCP, GLP, and standards for the reliability of application documents).

<h3>Medical Device Re-examination/Re-evaluation Related Consultation</h3>

Consultation related to re-examination, re-evaluation, and post-market surveillance evaluation after approval.

<h3>Brief Consultation</h3>

A consultation to receive answers to relatively minor questions in a short time. Each consultation is within 15 minutes (QMS investigation related is within 30 minutes).

<h3>Face-to-Face Consultation Preparation Meeting</h3>

A preliminary meeting to organize consultation matters and the content of submitted documents before applying for a full-scale face-to-face consultation. The fee for the preparation meeting is deducted from the subsequent face-to-face consultation fee.

In addition, "Priority Face-to-Face Consultation" is available for innovative medical devices, specific-use medical devices, and program medical devices designated for priority review.

<hr> <h2>3. How to Use Each Consultation Category</h2>

The practical guidelines for using each category are as follows:

<table> <thead> <tr> <th>Phase</th> <th>Recommended Consultation Category</th> </tr> </thead> <tbody> <tr> <td>Conception stage (considering development)</td> <td>General Medical Device Consultation, Brief Consultation</td> </tr> <tr> <td>Development plan formulation stage</td> <td>Medical Device Pre-Development Consultation, Face-to-Face Consultation Preparation Meeting</td> </tr> <tr> <td>Non-clinical trial / Clinical evaluation implementation stage</td> <td>Medical Device Protocol Consultation, Medical Device Evaluation Consultation</td> </tr> <tr> <td>Just before application</td> <td>Medical Device Pre-Submission Consultation, Medical Device Reliability Standards Conformity Consultation</td> </tr> <tr> <td>Post-approval</td> <td>Medical Device Re-examination/Re-evaluation Related Consultation, Medical Device Post-market Surveillance Evaluation Consultation</td> </tr> </tbody> </table>

While it is ideal to utilize multiple consultation categories incrementally from the early stages of development, due to cost and time constraints, it is recommended to conduct at least two consultations: Pre-Development Consultation and Pre-Submission Consultation.

<hr> <h2>4. Application Method and Flow to Implementation</h2>

The basic flow from application to implementation of face-to-face consultation is as follows:

<h3>Step 1: Reservation and Implementation of Face-to-Face Consultation Preparation Meeting</h3>

Before the main face-to-face consultation, the content of the consultation and submitted documents are organized and confirmed. A reservation request form is submitted via email, and it is generally conducted in the week after next.

<h3>Step 2: Submission of Request for Face-to-Face Consultation Schedule Adjustment</h3>

Submit a schedule adjustment request form to the PMDA Review Management Department, Review Management Division via email. There is a fixed acceptance date at the beginning of each month, and it must be submitted by the specified date two months prior to the desired month.

<h3>Step 3: Fee Payment and Application Form Submission</h3>

After schedule adjustment is completed, transfer the fee to the designated account and submit the application form.

<h3>Step 4: Submission of Consultation Documents</h3>

Submit consultation documents by mail, delivery, or via the Application Electronic Data System (Gateway System) by 3:00 PM on the Monday five weeks prior to the face-to-face consultation date.

<h3>Step 5: Implementation of Face-to-Face Consultation</h3>

Conducted in a face-to-face format, web conference format, or a combination thereof. Consultation time is approximately 1 to 2 hours depending on the category.

<h3>Step 6: Confirmation and Finalization of Advice Record</h3>

After the face-to-face consultation, PMDA creates an advice record and requests the consultant to confirm its content. After confirmation, it is finalized as an official record.

<hr> <h2>5. Documents to Prepare</h2>

The quality of submitted documents is critically important for effective utilization of face-to-face consultation. The generally required documents are as follows:

<h3>Consultation Matters Document</h3>

A document that clearly lists what you want to consult about. By clarifying the scope of consultation and narrowing down the issues, substantive discussions can be held within a limited time.

<h3>Product Overview Document</h3>

Includes product structure, raw materials, intended use, mechanism of action, and anticipated use environment. If the product is already approved overseas, include overseas approval documents.

<h3>Development Plan</h3>

Implementation plan for non-clinical trials and clinical evaluation, data acquisition policy, and schedule until application.

<h3>Summary of Existing Data</h3>

Summary of test data obtained overseas, CE mark or FDA 510(k) documents, and gap analysis with Japanese requirements.

<h3>Company's Own Viewpoint for Each Issue</h3>

Demonstrate your company's current policy and rationale for each consultation matter. It is more effective to approach it with the stance of "confirming whether our policy is appropriate" rather than "getting an answer from PMDA."

<hr> <h2>6. Overview of Fees</h2>

The fees for face-to-face consultation vary depending on the consultation category. Fees were partially revised on March 31, 2026, and it is essential to check the latest fee schedule on the PMDA official website.

<a href="https://www.pmda.go.jp/review-services/drug-reviews/user-fees/0001.html">https://www.pmda.go.jp/review-services/drug-reviews/user-fees/0001.html</a>

Small and medium-sized enterprises (SMEs) and venture companies may be eligible for a 50% subsidy system for fees (Innovative Medical Device Consultation and Approval Application Support Project) if they meet the requirements.

Note that for some categories (excluding items subject to the Sakigake Designation System), if the application is withdrawn after the face-to-face consultation application date but before the consultation implementation date, half of the fee will be refunded.

<hr> <h2>7. Tips for Maximizing Face-to-Face Consultation</h2>

From practical experience, the key points for effectively utilizing face-to-face consultation are as follows:

<h3>Narrow Down the Issues</h3>

The number of issues that can be handled in a single face-to-face consultation is limited. Focusing on 3 to 5 core issues of the development plan, rather than asking comprehensively, allows for deeper discussion.

<h3>Present Your Company's Viewpoint First</h3>

PMDA tends to provide more specific advice in response to questions like "We are considering this, what do you think?" rather than "What do you think?". Clearly stating your company's policy and rationale leads to constructive discussions.

<h3>Utilize Preparation Meetings</h3>

Face-to-face consultation preparation meetings contribute significantly to organizing consultation content, while the cost is effectively small as it is deducted from the main consultation fee.

<h3>Document Consultation Matters</h3>

What is recorded in the face-to-face consultation record has significant implications for subsequent reviews. Always confirm whether agreements made verbally are reflected in the written record.

<h3>Read PMDA Official Documents in Advance</h3>

PMDA publishes a vast amount of official guidance, notifications, and Q&As. Asking questions about "what is written in the guidance" during a face-to-face consultation is a waste of time and cost. It is effective to conduct thorough research in advance and focus on issues that cannot be judged from the guidance alone.

<hr> <h2>8. Points for Overseas Manufacturers to Pay Special Attention To</h2> <h3>Applicant must be a domestic MAH/DMAH</h3>

Overseas manufacturers cannot directly apply for face-to-face consultation. Applications must be made through a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) in Japan. If DMAH selection has not been completed, you cannot proceed to the face-to-face consultation stage.

<h3>Utilization of Web Conferencing Systems</h3>

Face-to-face consultations can be conducted via web conference. This allows head office staff of overseas manufacturers to participate and reduces travel costs. Requests for simultaneous interpretation systems must be submitted in advance.

<h3>Handling of English Documents</h3>

While it is possible to include some English documents in the consultation materials, consultation matters documents and primary submitted documents should, in principle, be prepared in Japanese. Accurate translation of technical terms affects the quality of the discussion.

<h3>Advice is based on Japanese regulatory requirements</h3>

There are cases where concepts accepted overseas are not accepted in Japan. It is important to confirm during face-to-face consultation that methods approved under EU MDR or FDA 510(k) cannot necessarily be applied directly in Japan.

<h3>Schedule Design with Time Allowance</h3>

It usually takes 2 to 3 months from the application for face-to-face consultation to its implementation. It is essential to incorporate the face-to-face consultation period into the development schedule.

<hr> <h2>9. Summary</h2>

The key points to effectively utilize PMDA face-to-face consultation are the following three:

<ol> <li><strong>Utilize incrementally</strong>: Use multiple times according to the development phase, such as confirming the overall framework in pre-development consultation and details in pre-submission consultation.</li> <li><strong>Quality of preparation determines the outcome</strong>: Clearly documenting consultation matters and your company's viewpoint allows for substantive discussions within a limited time.</li> <li><strong>Prioritize DMAH selection</strong>: For overseas manufacturers, DMAH is required for face-to-face consultation applications, so conclude the DMAH contract early.</li> </ol>

Although face-to-face consultation incurs fees, it is an investment that significantly reduces the time and cost until approval. "Getting pointed out by PMDA after application and having to rework" is definitely more costly than "aligning in advance through face-to-face consultation and surely obtaining approval." It is recommended to position face-to-face consultation as a crucial tool that determines the success of market entry into Japan.