Medical Device PMDA Approval Process: A Complete Guide from Application to Approval

To sell medical devices in the Japanese market, one of the following procedures is required: approval by the Minister of Health, Labour and Welfare, certification by a Registered Certification Body, or notification. Among these, the approval process, for which PMDA (Pharmaceuticals and Medical Devices Agency) is responsible for review, is an unavoidable hurdle for high-risk medical devices of Class III or higher and products with new functions. This article systematically organizes information from the selection of application categories to review periods and costs, based on official data. This content can be used as a reference for overseas manufacturers entering the Japanese market.

Table of Contents

• 1. What is PMDA Approval: Differences from Certification and Notification
• 2. Determining the Application Category: How to Choose from the 4 Categories
• 3. Documents Required for Approval Application
• 4. Estimated Review Period: Latest Results by Category
• 5. Main Steps to Approval
• 6. Estimated Costs
• 7. Key Points for Overseas Manufacturers to Note
• 8. Summary

1. What is PMDA Approval: Differences from Certification and Notification

Pre-market procedures for medical devices are divided into three stages depending on the risk class.

Approval (Approval by the Minister of Health, Labour and Welfare) This procedure involves approval by the Minister of Health, Labour and Welfare based on the PMDA's review results. It applies to Class III (highly controlled medical devices), Class IV (highly controlled medical devices that are highly invasive), and Class II products for which no certification standards exist.

Certification (Third-Party Certification) This procedure involves a Registered Certification Body (RCB) confirming conformity to certification standards and granting certification. It applies to Class II controlled medical devices for which certification standards have been established.

Notification This applies to Class I (general medical devices), which can be sold simply by notifying the PMDA.

This article focuses on the "approval" process, which is the most complex and difficult.

2. Determining the Application Category: How to Choose from the 4 Categories

PMDA approval applications are categorized into the following four types. The selection of the category is extremely important strategically, as it directly impacts the review period and required documents.

• New Medical Devices: Medical devices whose structure, usage, efficacy, effect, or performance are "clearly different" from already approved medical devices. Clinical evaluation is generally mandatory, and many cases go through deliberation by a subcommittee of the Pharmaceutical Affairs and Food Sanitation Council. Post-market surveillance is also generally required.
• Improved Medical Devices (with clinical data): Medical devices that do not fall into either new medical devices or generic medical devices, and require clinical evaluation. These have limited novelty but cannot claim equivalence to already approved products.
• Improved Medical Devices (without clinical data): Improved medical devices that do not require clinical evaluation. This applies when the difference from an already approved product is small, and safety and performance can be demonstrated through non-clinical trials alone.
• Generic Medical Devices: Medical devices whose structure, usage, efficacy, effect, and performance are recognized as "substantially equivalent" to already approved medical devices. Clinical trials are not required, and the shortest review period can be expected.

It is recommended to confirm the category determination through PMDA face-to-face consultation (pre-consultation, general medical device consultation, etc.). Applying under the wrong category can lead to significant delays if a category change is requested after the application is accepted.

3. Documents Required for Approval Application

The basic documents to be submitted at the time of application are as follows. Additional documents may be required depending on the product's characteristics.

• Manufacturing and Marketing Approval Application Form
• Summary Technical Documentation (STED)
• Documents related to design and development
• Documents related to performance and specifications
• Documents related to stability and durability
• Documents related to the intended use or effect specified by law
• Documents related to manufacturing methods
• Documents related to clinical evaluation (depending on the category)
• Documents related to risk management
• Draft package insert

These are structured to demonstrate conformity to the essential requirements for medical devices. Test data conducted overseas and CE mark, FDA 510(k) documents can also be utilized, but a gap analysis with Japanese requirements is essential.

4. Estimated Review Period: Latest Results by Category

According to PMDA's published data for FY2024 (R6), the median total review period for new medical devices (standard items) is 11.7 months (80th percentile). This is below the target of 14 months, indicating that PMDA's review efficiency has been improving in recent years.

Estimated Standard Review Periods by Application Category

However, these are merely estimates. The actual period may vary depending on the quality of the application documents, the time taken to respond to PMDA inquiries, and the timing of the QMS conformity assessment. In particular, for manufacturers with overseas manufacturing sites, coordination for QMS conformity assessment tends to be prolonged.

5. Main Steps to Approval

The typical flow to obtain approval is as follows:

1. Step 1: Develop a Development Strategy - Determine the application category, necessity of clinical evaluation, and comparison with certification routes.
2. Step 2: Utilize PMDA Face-to-Face Consultation - Confirm PMDA's perspective through general medical device consultations, pre-development consultations, pre-application consultations, etc. This is especially recommended for overseas manufacturers.
3. Step 3: Prepare Application Documents - Prepare STED, Clinical Evaluation Report (CER), risk management documents, etc. Translation of overseas documents and alignment with Japanese requirements are key.
4. Step 4: Application Acceptance - Submit application documents to PMDA. After acceptance, document review begins.
5. Step 5: Respond to Inquiries - Respond to questions (inquiries) from reviewers in writing or through meetings. The quality and speed of responses directly impact the review period.
6. Step 6: QMS Conformity Assessment - Assess whether the manufacturing control and quality control system conforms to Japan's QMS Ordinance. This includes document review and on-site inspection.
7. Step 7: Notification of Review Results and Approval - For new medical devices, approval is granted by the Minister of Health, Labour and Welfare after deliberation by the Pharmaceutical Affairs and Food Sanitation Council.

6. Estimated Costs

PMDA fees for approval applications vary depending on the application category and class classification. Estimates for typical cases are as follows:

In addition to these, QMS conformity assessment fees, consulting fees, translation fees, and clinical evaluation-related fees are required. For a total estimate, always check the latest PMDA fee schedule. There is also a 50% subsidy system for fees for small and medium-sized enterprises and startups through the "Innovative Medical Devices, etc. Consultation and Approval Application Support Project."

7. Key Points for Overseas Manufacturers to Note

Overseas manufacturers tend to encounter difficulties in the following areas when obtaining PMDA approval in Japan:

• Securing a Designated Marketing Authorization Holder (DMAH): Overseas manufacturers cannot directly apply and must apply through a Japanese Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH). The selection of a DMAH requires careful consideration as it affects the business continuity after approval.
• Foreign Manufacturer Registration (FMR): Overseas manufacturing sites must obtain certification or registration as a foreign manufacturer from the PMDA. This is a separate procedure from the approval application but is a prerequisite for approval.
• Responding to QMS Conformity Assessment: ISO 13485 certification alone does not automatically prove conformity to Japan's QMS Ordinance. It is necessary to bridge the gap with Japan's unique requirements.
• Quality of Translation: Application documents must be submitted in Japanese. Mistranslations of technical terms can not only delay the review but also undermine trust from regulatory authorities. A translation system proficient in medical device regulations is essential.

8. Summary

The following three points should be emphasized for successfully navigating the PMDA approval process:

1. Accurate Determination of Application Category: This significantly affects the review period and required documents, so confirm with PMDA face-to-face consultation at an early stage.
2. Quality of Application Documents: The consistency of STED, clinical evaluation, and risk management determines the review period.
3. Procedures Specific to Overseas Manufacturers: Plan DMAH selection, foreign manufacturer registration, and QMS conformity assessment in parallel with the approval application.

Obtaining approval is merely the starting point for entering the Japanese market. After approval, continuous efforts are required for health insurance listing, establishing sales channels, and post-market safety management. Designing a comprehensive regulatory strategy from an early stage is the greatest key to minimizing the time and cost until market launch.