Medical Device Reimbursement in Japan
Medical device insurance coverage in Japan determines how a device is evaluated and under what conditions it can be used in insured medical care. This is separate from regulatory approval, certification, or marketing notification; completing the regulatory procedure does not automatically establish an individual material price. Device costs may be included in a technical fee or assigned a separate material price as specified reimbursable medical materials.
Difference Between Technical Fees and Material Prices
For medical devices used in insured medical care, the cost of some devices is included in a technical fee under the medical fee schedule, while others are assigned a material price as specified reimbursable medical materials.
For specified reimbursable medical materials, reimbursement is generally based on the standard material price of the functional category to which the product belongs. A functional category is an insurance classification based on factors such as intended use and function.
Insurance coverage concerns the treatment of a device within insured medical care; the reimbursement price is its material valuation under that system, while the manufacturer's selling price is a commercial transaction price. Review the clinical procedure and relevant technical fee or functional category as well as the desired selling price.
Main Insurance Coverage Decision Categories
The decision category is considered based on whether the product can be handled within existing medical fee or material evaluations or whether a new evaluation or a change in treatment is required.
Medical devices evaluated as included in an existing medical fee and not falling under A2, A3, or other categories.
Medical devices evaluated under a specified medical fee item and falling within a designated category of medical devices subject to specified medical fee calculation.
Considered when the product is evaluated under an existing medical fee but a change to calculation-related notes or other conditions is required.
Considered when the product can be evaluated under an existing or provisional functional category.
Considered when the product is evaluated under an existing functional category but a change to the category definition, calculation-related notes, or other conditions is required.
Considered when a time-limited improvement premium for an existing functional category requires deliberation by the Central Social Insurance Medical Council.
Considered when the technology used with the device is already evaluated under the existing medical fee schedule and deliberation is required to establish a new material functional category.
Considered when the technology using the medical device requires evaluation under a new technical fee and deliberation on insurance coverage.
Other categories include R for remanufactured single-use medical devices and F for products not suited to insurance coverage. The applicable conditions and exclusions should be checked against the latest notifications.
C2 does not mean that both a new material functional category and a new technical fee are always required. The key point is whether evaluation under a new technical fee is necessary.
In addition, some medical devices falling under A1 are separately designated as not requiring submission of an insurance coverage application form. The same application documents are not required for every medical device.
Process for Obtaining Insurance Coverage
- 01
Confirm the Clinical Procedure and Existing Evaluation
Confirm the target patients, intended use, and clinical workflow. Review the technical fee used with the product, existing materials, and the definitions and calculation conditions of relevant functional categories.
- 02
Confirm the Decision Category and Required Procedures
Determine whether existing evaluations are sufficient or whether a new evaluation or change in treatment is required. Depending on the product and decision category, confirm whether an insurance coverage application form is required and how it should be submitted.
- 03
Prepare Documentation in Parallel with the Regulatory Submission
Organize information shared with the regulatory submission, such as intended use, product specifications, and clinical data. Confirm that the explanation for insurance coverage does not conflict with the scope accepted through the regulatory process.
- 04
Confirm the Decision and Commercial Launch Timing
After the required application, responses to inquiries, and deliberation, confirm the decision category, functional category, insurance coverage start date, and calculation conditions. Do not set the launch schedule based only on completion of the regulatory process; coordinate it with shipment preparation as well.
Checklist for Commercial Launch
For product-specific review, it is useful to organize the following information.
- Trade name, product specifications, and applicable models
- Intended use in Japan, target patients, and the procedure in which the device will be used
- Status of regulatory approval, certification, or marketing notification in Japan
- Relevant technical fees, existing materials, and functional categories
- Documentation required for insurance coverage and the responsibilities of each company
- Insurance coverage start date and planned commercial launch date
Submission conditions, whether deliberation is required, and processing time vary by decision category. Specific schedules should be confirmed based on the latest notifications and the circumstances of the individual application.
When You Need a Detailed Review of C1 Documentation and Pricing
When seeking a new material functional category, it is necessary to separately organize comparisons with existing categories and the basis for the proposed price. Selection of a similar functional category, clinical usefulness, adjustment premiums, and foreign price comparisons are explained in more detail on the following page.
Frequently Asked Questions
Are Regulatory Approval and Insurance Coverage the Same?
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No. The regulatory procedure and the method and conditions of evaluation under insured medical care must be reviewed separately. Obtaining regulatory approval alone does not determine an individual material price.
Are All New Products Classified as C1?
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No. Some products can be evaluated under existing technical fees or functional categories. Do not determine the category simply because a product is new; confirm its relationship to existing evaluations.
Should Reimbursement Preparation Start Only After Approval?
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Starting the review in parallel once the intended use and clinical data are being organized can make it easier to coordinate the required documentation and commercial launch schedule. The formal submission timing should be confirmed based on the decision category and the applicable notification requirements.
Is the Reimbursement Price the Same as the Manufacturer's Selling Price?
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Not necessarily. The material price under the insurance system and the transaction prices among manufacturers, distributors, and medical institutions should be considered separately.
References and Reimbursement Price Search
The two notifications below were issued on February 13, 2026 and apply from June 1, 2026. The issue date is not the effective date; the coverage start date for an individual product must also be confirmed separately. For an actual application, check subsequent amendments and corrections on the MHLW revision page.
Contact Us About Medical Device Reimbursement
Tell us how the product will be used and the status of the regulatory process. We will review its relationship to existing medical fees and functional categories and organize the decision category and preparations that should be considered.
Related guides: Medical Device Registration & Market Entry in Japan · Medical Device Approval Process in Japan
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