Reimbursement of Medical Devices and In Vitro Diagnostics

This document systematically organizes the practical procedures, timing, and key considerations related to insurance coverage (reimbursement listing) of medical devices and in vitro diagnostic products. Based on publicly available information from the Ministry of Health, Labour and Welfare (MHLW) and PMDA, it comprehensively covers the information needed by development companies when formulating reimbursement strategies.


Chapter 1: Overview and Basic Principles of Insurance Coverage Listing
1.1 Overview of the Insurance Coverage Listing System
The insurance coverage listing of medical devices and in vitro diagnostic products is the procedure conducted by the MHLW after regulatory approval is obtained, to determine eligibility and pricing under the public health insurance system. While regulatory approval is granted from the perspective of "safety and efficacy," insurance coverage listing is evaluated from the perspective of "medical usefulness and cost-effectiveness."
Details are posted on the MHLW's "Insurance Coverage for Medical Devices and In Vitro Diagnostics." In practice, it is fundamental to read the guidebook posted on the same page carefully.
1.2 Insurance Coverage Categories for Medical Devices
The insurance coverage categories for medical devices are as follows.

• Category A1 (Comprehensive): Cases where the technology using the medical device is evaluated by items listed in the diagnostic fee calculation method (excluding A2 and A3). Listing timing: as needed (anytime)
• Category A2 (Specific Comprehensive): Cases falling under the specific diagnostic fee-calculating medical device category evaluated under specific diagnostic fee items. Listing timing: 1st of the following month (items received by the 10th of each month)
• Category A3 (Existing Technology with Changes): Evaluated by items listed in the calculation method notification, but involving changes in considerations, etc. Listing timing: 1st of the month following the decision month
• Category B1 (Existing Function Category): Cases falling under an existing function category. Listing timing: 1st of the following month (items received by the 10th of each month)
• Category B3 (Time-Limited Improvement Surcharge / Provisional Function Category): Evaluated under existing technology, but requires deliberation by the Central Social Insurance Medical Council (Chuikyo) to add a time-limited improvement surcharge to an existing function category. Listing timing: 4 times per year (March, June, September, December)
• Category C1 (New Function): Evaluated by items listed in the calculation method notification, but requires Chuikyo deliberation for the establishment of a new function category. Listing timing: 4 times per year (March, June, September, December)
• Category C2 (New Function / New Technology): Requires setting a new technology fee for evaluation, and requires Chuikyo deliberation on whether insurance coverage is appropriate. Listing timing: 4 times per year (material price) / once every 2 years (technology fee)
• Category R (Remanufactured): Remanufactured single-use medical devices requiring Chuikyo deliberation for the establishment of a new function category. Listing timing: 4 times per year (March, June, September, December)

"Appendix 1: Types of Categories and Insurance Coverage Procedures," "Handling of Insurance Coverage, etc., for Medical Devices," "Appendix 1," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026
Category C2 is applied to the most innovative medical devices, with both material prices and diagnostic fee technology fees being subject to evaluation.
1.3 Insurance Coverage Categories for In Vitro Diagnostics
In vitro diagnostic products are subject to a separate category system (Category E) from medical devices. The key feature is that, unlike medical devices where a material price is set, points (examination fees) are set for each examination item.

• Category E1 (Existing Item): Both measurement items and measurement methods are existing. Listing timing: 20 days after the date of receipt of the insurance coverage application
• Category E2 (Existing Item with Changes): Measurement items are existing but measurement methods, etc., are new, and does not fall under E3. Listing timing: 1st of the month following the decision month
• Category E3 (New Item / Improved Item): Measurement items are entirely new, or the clinical significance has been substantially improved through technical improvement even for existing items. Listing timing: 1st of the month following the decision month

"Handling of Insurance Coverage for In Vitro Diagnostics," "1-(1), Appendix 1," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026
Key Points for Category Selection:

• Category E1 is the simplest route, with minimal procedures and review. Existing examination points are applied as-is
• Category E2 applies when the measurement method is new (e.g., automation, improved precision, etc.) but the measurement target (examination item) is existing. Determined through deliberation by the Hozaisen (Insurance/Materials Specialist Organization)
• Category E3 applies when measurement items are new (e.g., novel biomarkers) or when the product involves existing items but with substantially improved clinical significance through technical improvement

Challenge Application for Category E1:
This is a system that allows a re-evaluation application based on usage results when, after insurance coverage listing as Category E1, the initially applied examination points diverge from actual conditions.

• Manufacturers/sellers wishing to submit a challenge application must submit reference materials for a plan concerning the content of re-evaluation desired, data collection methods, and evaluation methods at the time of submitting the insurance coverage application, or by the day one year after the date of insurance coverage.
  • "Handling of Insurance Coverage for In Vitro Diagnostics," "2-(1)," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026

Sample entries and forms are posted on the MHLW's "Sample Entries for Insurance Coverage Applications for In Vitro Diagnostics."


Chapter 2: Standard Process and Timeline to Insurance Coverage Listing
2.1 Steps Prior to Regulatory Approval
It is advisable to begin preparation for insurance coverage listing in parallel with the regulatory approval application.
(1) Preliminary Consultation with the Industry and Information Division (Sankajo)
During the regulatory approval application, conduct a preliminary consultation with the MHLW Insurance Bureau Medical Affairs Division's Industry and Information Division. Consultation content includes the following:

• Anticipated insurance coverage category (Category B vs. Category C, or E1–E3)
• Presence/absence and comparison of similar function categories / similar examination items
• Content of the insurance coverage application (draft review)
• Types and scope of required evidence

It is said to be advisable to complete the preliminary consultation before obtaining regulatory approval. Since major changes to the application content are not possible after the regulatory approval application is submitted, the "parallel schedule" of advancing insurance coverage preparations in parallel during that review period has become the standard practical approach.
(2) Drafting the Insurance Coverage Application
Draft the insurance coverage application in parallel with the preliminary consultation.

• It is advisable to allow several months for this process.
• The Sankajo review is said to take approximately 1 to 1.5 months.
• Form and sample entries (medical devices): MHLW "Sample Entries for Insurance Coverage Applications for Medical Devices"
• Form and sample entries (in vitro diagnostics): MHLW "Sample Entries for Insurance Coverage Applications for In Vitro Diagnostics"

The draft is submitted to the Sankajo for review, and revisions are made to incorporate the feedback received.
2.2 Steps After Obtaining Regulatory Approval
(1) Formal Submission of the Insurance Coverage Application
After obtaining regulatory approval, promptly submit the insurance coverage application formally.

• The submission form for medical devices is specified in the MHLW "Handling of Insurance Coverage, etc., for Medical Devices"
• The submission form for in vitro diagnostics is specified in "Handling of Insurance Coverage for In Vitro Diagnostics"

(2) Medical Affairs Division Hearing
Approximately 1 to 2 months after submission of the insurance coverage application, a hearing is conducted by the MHLW Insurance Bureau Medical Affairs Division (applicable to Category E2/E3 in vitro diagnostics and Category C1/C2 medical devices). The hearing confirms the following:

• Details of functions, performance, and measurement principles
• Differences from similar products / similar tests
• Evidence of clinical usefulness
• Anticipated actual usage and market size
• Basis for the desired material price / examination points

(3) Deliberation at the Insurance/Materials Specialist Organization (Hozaisen)
After the Medical Affairs Division hearing, deliberation is conducted at the Insurance/Materials Specialist Organization (Hozaisen), a subordinate body of the Chuikyo.
Standard Processing Times:

• Medical Devices Category C2: Within 5 months from the 1st of the month following the submission month (limited to those where the standard administrative processing period for review is secured at 100 days or more)
• Medical Devices Category C1 / B3 / R: Within 4 months from the 1st of the month following the submission month (limited to those where the standard administrative processing period for review is secured at 80 days or more)
• In Vitro Diagnostics Category E2/E3: Within 5 months from the 1st of the month following the submission month (limited to those where the standard administrative processing period for review is secured at 100 days or more)

"Handling of Insurance Coverage, etc., for Medical Devices" Notification dated February 13, 2026 (Medical Devices), "Handling of Insurance Coverage for In Vitro Diagnostics" Notification dated February 13, 2026 (In Vitro Diagnostics)
(4) Deliberation at the Medical Technology Assessment Subcommittee (Only for Medical Devices Category C2 / When Applicable)
Even in the case of Category C2, deliberation at the Medical Technology Assessment Subcommittee is not mandatory. The Hozaisen determines whether "deliberation at the Medical Technology Assessment Subcommittee is required."
Deliberation at the Medical Technology Assessment Subcommittee is required only when the Hozaisen determines that the following conditions apply:

• Cases where simultaneous revision of similar existing technologies is necessary to ensure consistency in evaluation with similar existing technologies
• Medical devices used for the purpose of performing medical technologies not covered by insurance
• Devices intended to perform technologies for which there is no technology fee for online medical care, via online medical care
• Cases used across multiple fields where different diagnostic fee points are calculated for each field
• Cases requiring deliberation on the establishment of new management fees (medical management fees, home care guidance management fees, etc.)
  • "Handling of Insurance Coverage, etc., for Medical Devices," "5," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026

When deliberation is deemed necessary, companies prepare and submit a "Proposal for the Medical Technology Assessment Subcommittee" based on the form notified by the MHLW.

• "Handling of Insurance Coverage, etc., for Medical Devices," "5-(5)," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026

(5) Final Approval and Notification at the Chuikyo General Assembly
Based on the results of deliberations at the Hozaisen (and the Medical Technology Assessment Subcommittee where applicable), the Central Social Insurance Medical Council (Chuikyo) General Assembly grants final approval. After approval and following official gazette notification, insurance coverage listing is finalized. The latest schedule can be confirmed on the Central Social Insurance Medical Council (Chuikyo) Official Page.
2.3 Summary of Listing Timing

• Medical Devices Category A1 / B1: As needed (1st of the following month)
• Medical Devices Category C1 / C2 / B3 / R (material price): 4 times per year (1st of March, June, September, December)
• Medical Devices Category C2 (when seeking a new technology fee): At the time of diagnostic fee revision (once every 2 years, June 1st of even-numbered years)
• In Vitro Diagnostics Category E1: 20 days after receipt date (as needed)
• In Vitro Diagnostics Category E2/E3: 1st of the month following the decision month

"Handling of Insurance Coverage, etc., for Medical Devices," "4-(6)," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026
"Handling of Insurance Coverage for In Vitro Diagnostics," "2-(1)イ," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026


Chapter 3: Special Considerations for Category C2
3.1 Two-Year Cycle for Technology Fee Listing
When seeking the establishment of a new technology fee in the diagnostic fee under Category C2, the evaluation and official notification of the technology fee can only be conducted at the time of diagnostic fee revision (in principle, once every 2 years, on June 1st of even-numbered years). Therefore, unlike material prices (which can be listed 4 times per year), the opportunity for technology fee listing is effectively once every 2 years.
Diagnostic fee revisions are implemented in principle once every 2 years (even-numbered years) based on the Health Insurance Act, etc., and from fiscal year 2024 onward, the effective date has been changed from the conventional April 1st to June 1st. Since missing the timing can result in a delay of up to 2 years, schedule management working backward from the target revision year is essential.
3.2 Provisional Points and Determined Points
Medical devices under Category C2 are often listed at "provisional points (temporarily utilizing existing similar technology fees at the time of listing)," and the formal "determined points" are said to be notified at the time of diagnostic fee revision.


Chapter 4: Submission Documents and Submitters
4.1 Documents Submitted by Companies

• Insurance Coverage Application: Submitted as needed after obtaining regulatory approval. It is advisable to go through preliminary consultation with the Sankajo and draft review.
• Proposal for the Medical Technology Assessment Subcommittee (only when deliberation is deemed necessary / only for Medical Devices Category C2): By the earlier of within 3 months from the Hozaisen deliberation date or by the end of September of the year before the diagnostic fee revision. Prepared based on the MHLW notification form.

"Handling of Insurance Coverage, etc., for Medical Devices," "2-(1)," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026
4.2 Documents Submitted by Academic Societies

• Appropriate Use Guidelines / Appropriate Use Guide: Before and after submission of the insurance coverage application. It is advisable for companies and academic societies to collaborate on preparation.
• Request for Early Introduction: As needed. Submitted as the collective opinion of the academic society.
• Medical Technology Assessment Proposal (Proposal from academic societies toward diagnostic fee revision)

Important Distinction: The "Proposal for the Medical Technology Assessment Subcommittee" submitted by companies and the "Medical Technology Assessment Proposal" submitted by academic societies in the diagnostic fee revision process are separate documents. The former is prepared and submitted by companies when the Hozaisen deems it necessary during the insurance coverage deliberation process; the latter is proposed by academic societies toward the biennial diagnostic fee revision.
4.3 Importance of Academic Society Collaboration
It is advisable to build relationships with academic societies (especially insurance committees) and KOLs from an early stage. Academic society cooperation is indispensable particularly in the following situations:

• Formulation of appropriate use guidelines
• Preparation and submission of medical technology assessment proposals (at the time of diagnostic fee revision)
• Acquisition of the Gaihoren Trial Plan (for surgical technologies)
• Submission of early introduction requests

Chapter 5: Supporting Materials for Technology Fee Calculation
5.1 Utilization of the Gaihoren Trial Plan
For new technologies led by surgical academic societies, the Gaihoren Trial Plan prepared by the Gaihoren (Federation of Surgical Societies Social Insurance Committee) is regarded as the standard supporting material for technology fee calculation.
The Gaihoren Trial Plan is a supporting document demonstrating the appropriateness of technology fees for surgeries, procedures, etc., and calculates an estimated technology fee based on data such as personnel costs of the medical staff involved, time required, and costs of materials used.
5.2 Supporting Materials for Technologies Outside the Surgical Field
For technologies led by academic societies outside the surgical field, such as neurology and rehabilitation, since they do not go through the Gaihoren, other supporting materials (registry data of academic societies, primary research data, etc.) are said to be necessary. In either case, when company-led, clinical data from the regulatory approval process becomes important.
5.3 Data Collection During Clinical Trials
In addition to collecting evidence on efficacy and safety for the purpose of obtaining regulatory approval, it is advisable to collect data necessary for technology fee calculation from the clinical trial stage. PMDA's "Points to Note on Obtaining Regulatory Approval for Insurance Coverage" also points out the importance of integrated design of regulatory and insurance aspects.
Examples of items that are advisable to record and collect separately from the clinical trial evaluation items are as follows:

• Time for preparation before the procedure
• Time for the procedure (implementation)
• Time for post-procedure cleanup
• Comparison of the above times with alternative (existing) technologies
• How many cases are needed for proficiency
• Types and number of medical staff required
• Types and unit prices of disposable materials used
• Data contributing to shorter hospitalization periods
• Frequency of tests
• Time required for determination
• Requirements for equipment and space at the facility

These do not need to be incorporated into the primary evaluation items of the clinical trial protocol, but collecting this data makes it easier to compare with existing technologies and also leads to a better understanding of health economics.


Chapter 6: Appeals Process
6.1 Overview of the Process
In cases of dissatisfaction with the category determination, a system exists that allows submission of a written opinion to request a second deliberation by the specialist organization (limited to once).
"Handling of Insurance Coverage, etc., for Medical Devices," "6-(2)," MHLW Insurance Bureau Medical Affairs Division, Notification dated February 13, 2026
However, in practice, the following points require attention:

• In practice, there appear to be few cases where the deliberation result has been overturned through an appeal.
• Filing an appeal results in a loss of time, creating the risk of missing the earliest possible listing opportunity.

Taking these into account, it is advisable to thoroughly prepare to achieve approval on the first attempt, rather than planning around this system.


Chapter 7: Utilizing the Breakthrough Medical Devices Designation System
7.1 Overview of the System
For innovative medical devices targeting Category C2, it is advisable to consider utilizing the MHLW's "Breakthrough Medical Devices and In Vitro Diagnostics Designation System."
7.2 Key Benefits
The key benefits obtainable through designation are as follows:

• Becomes eligible for priority consultation and priority review by PMDA, with expected shortening of the regulatory review period (target: 6 months)
• A concierge (review partner) is assigned at PMDA, enabling regular progress management in line with the approval review schedule
• Through "Breakthrough Comprehensive Evaluation Consultation" coordinated with the MHLW, cross-ministry integrated support spanning regulatory affairs and insurance can be received
• Details of the review and consultation process are posted on PMDA's "Breakthrough Pharmaceutical Designation System (Sakigake Review Designation System)" page

Chapter 8: Integrated Strategy for Regulatory and Insurance Affairs
8.1 Linkage Between Generic Names and Insurance Categories
The definition and scope of generic names that can be confirmed on PMDA's "Medical Device Generic Name Database" directly affects the judgment on insurance coverage category (Category B: existing function vs. Category C: new function). If PMDA consultations are advanced within the scope subsumed under existing generic names, differentiation under C2 may become difficult; therefore, it is advisable to be mindful of the insurance coverage category from the stage of setting the generic name.
8.2 Design of "Intended Purpose / Effect" Description
The content of the "intended purpose / effect" description in the regulatory application becomes the starting point for usefulness evaluation in the insurance review. It is advisable to design the description with consistency between the regulatory and insurance aspects.
8.3 Utilization of PMDA Consultations and Sankajo Consultations
Make effective use of PMDA's "RS General Consultation / RS Strategy Consultation" and preliminary consultations with the MHLW Sankajo.


Appendix: Key Reference Links
Ministry of Health, Labour and Welfare
"Insurance Coverage for Medical Devices and In Vitro Diagnostics (including guidebook and forms)"
"Handling of Insurance Coverage, etc., for Medical Devices (Notification dated February 13, 2026)"
"Handling of Insurance Coverage for In Vitro Diagnostics (Notification dated February 13, 2026)"
"Points to Note on Handling of Insurance Coverage for In Vitro Diagnostics (Notification dated February 13, 2026)"
"Sample Entries for Insurance Coverage Applications for In Vitro Diagnostics"
"Central Social Insurance Medical Council (Chuikyo)"
"Breakthrough Medical Devices and In Vitro Diagnostics Designation System"
"Evaluation Methods for Medical Technologies Toward the FY2024 Diagnostic Fee Revision (Draft)"
PMDA
"Insurance Coverage and Stable Supply of Medical Devices"
"Points to Note on Obtaining Regulatory Approval for Insurance Coverage"
"Medical Device Generic Name Database"
"RS General Consultation / RS Strategy Consultation"
"Breakthrough Review Designation System"
Related Organizations
Gaihoren "Federation of Surgical Societies Social Insurance Committee"
"Insurance Coverage Process for Innovative Medical Devices"


Disclaimer
This document is prepared for the purpose of providing general information and is not intended as individual advice for specific companies or cases. Since the system is subject to ongoing revisions, please confirm the latest information on official websites such as the MHLW and PMDA. While the MHLW guidebook should be your primary point of reference , it is also advisable to utilize specialized insurance consultants as needed.

Reimbursement Summary Ver.