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Day: November 8, 2026

When Does Japan’s Advanced Medical Care B Make Sense for Medical Device Companies?

2026-11-08 Doing Business in Japan , Medical Devices , Medtech , Pharmaceutical 0

An opportunity to enable clinical use before reimbursement and build relationships with Japanese healthcare institutions

Why Should Medical Device Companies Pay Attention?

Japan’s Advanced Medical Care B system (先進医療B) can offer a route for selected medical technologies to be used in clinical practice at designated Japanese medical institutions before they become eligible for reimbursement under Japan’s National Health Insurance (NHI) system.

For international medical device companies, this may create several potential advantages:

  • Earlier clinical use: The opportunity for selected patients to receive a technology in a designated medical institution before it is covered by NHI.
  • Experience in Japanese clinical practice: Physicians and hospitals can gain experience using the technology in a defined clinical setting.
  • Physician engagement: The framework can help establish relationships with Japanese specialists and potential clinical champions.
  • Clinical and commercial preparation: Companies can better understand how a technology fits into Japanese clinical workflows and what may be required for broader adoption.
  • Potential progress toward reimbursement: The evaluation process can support consideration of whether the technology should ultimately be included in the NHI system.

However, Advanced Medical Care B is not a general market-entry route, a substitute for medical device approval, or a guaranteed source of pre-approval revenue. Its potential value depends on the technology, the clinical need, the participating institution and the company’s broader Japan strategy.

How Does the Application Process Work?

One important point for overseas manufacturers to understand is that a medical device company cannot apply directly for Advanced Medical Care B designation.

The application must be made by a qualifying medical institution to Japan’s Ministry of Health, Labour and Welfare (MHLW). The institution must meet the applicable facility requirements for the specific technology and its proposed clinical application.

Designation is therefore specific to both the medical institution and the technology. It is not a general designation granted to a manufacturer’s product that can then be used at any hospital.

Applications undergo expert-panel review, and the process typically takes approximately six months, although the actual timeline can vary depending on the application and review process.

For manufacturers, this means that identifying and working with an appropriate Japanese hospital and clinical investigator is an essential first step. The company may provide technical information, clinical evidence and other support, but the medical institution is the applicant and must take responsibility for meeting the relevant requirements.

What Types of Medical Devices Might Be Relevant?

Advanced Medical Care B can apply to medical technologies involving unapproved medical devices or approved devices used outside their approved indications or conditions of use, where the proposed technology requires focused evaluation of safety and effectiveness.

Potentially relevant examples may include:

  • Innovative interventional devices and procedures.
  • New surgical and robotic technologies.
  • Advanced imaging and diagnostic technologies.
  • Novel implants and other therapeutic devices.
  • New clinical applications or indications for existing devices.
  • Technologies with promising overseas experience but limited evidence or clinical experience in Japan.

These are illustrative categories, not a list of automatically eligible products. Eligibility is assessed in relation to the specific technology, clinical application, supporting evidence, proposed protocol and capabilities of the medical institution.

The distinction is important: the framework applies to a defined medical technology and its use at a designated institution, not simply to a manufacturer’s product as a whole.

When Should a Company Explore Advanced Medical Care B?

For an international medical device company, there are several situations where investigating this framework may be worthwhile.

1. There is a need for clinical use before NHI reimbursement

A technology may have a clear clinical rationale but not yet have an established reimbursement route in Japan. Advanced Medical Care B may provide an opportunity for its use in a defined clinical setting, with the advanced medical treatment component generally paid for by the patient.

This can be particularly relevant where there is a strong clinical need and a specialist physician prepared to introduce the technology.

2. Japanese clinical experience would help establish adoption

Some medical technologies require more than regulatory clearance to gain acceptance. Physicians need to understand how a device performs in practice, how it fits into existing procedures and workflows, and what benefits it offers compared with current treatment options.

Advanced Medical Care B may provide a structured opportunity for participating physicians and institutions to gain this experience.

This is clinical care under an evaluation framework, not a conventional GCP clinical trial. Companies should understand the distinction when considering the type of evidence generated and its potential uses.

3. There is a strong Japanese clinical champion

A committed physician or medical institution is often central to the feasibility of this approach.

The technology must address a meaningful clinical need, and the institution must be willing and able to take responsibility for the application, meet the facility requirements and conduct the proposed treatment and evaluation.

Without an appropriate institutional partner, the manufacturer cannot independently move the process forward.

4. There is a credible opportunity to progress toward reimbursement

The framework may be worth investigating where there is a realistic prospect that the technology could eventually be considered for NHI coverage.

Companies should assess the potential patient population, clinical value, competing treatments, likely patient out-of-pocket costs and the commercial implications of future reimbursement.

First Understand the Conventional Japanese Approval Pathway

Before considering Advanced Medical Care B, manufacturers should establish what is actually required to make their device available in Japan.

Japan does accept appropriate foreign clinical data in medical device applications. A Japanese clinical study is not automatically required simply because a product is being introduced into the Japanese market.

The regulatory route depends on the device’s classification and whether applicable Japanese certification standards exist.

In simplified terms:

  • Notification (届出): Generally applies to Class I medical devices.
  • Third-party certification (認証): Applies to Class II and certain Class III devices where an applicable certification standard exists.
  • Marketing approval (承認): Required for devices outside the notification and certification routes, including Class IV devices. These applications are reviewed by PMDA.

The appropriate first step is a regulatory gap assessment and, where appropriate, consultation with PMDA. This helps determine whether existing overseas evidence is sufficient, whether additional Japanese data may be needed, and what development or regulatory work remains.

Advanced Medical Care B should be considered separately from this approval assessment. It is not a shortcut through the PMDA review process.

What Is the Potential Business Value?

The potential value of Advanced Medical Care B is primarily related to clinical use, institutional experience and the evaluation of a technology for possible future NHI reimbursement.

For a company with an appropriate technology and hospital partner, it may offer:

Earlier clinical use before reimbursement

Selected patients may be able to receive the technology at a designated institution before the advanced medical treatment becomes covered by NHI.

Physician and institutional experience

Participating physicians can gain practical experience with the technology, potentially helping establish clinical familiarity and support future adoption.

Information for reimbursement evaluation

The framework involves evaluation and reporting of clinical outcomes. This information is relevant to the assessment of the technology for potential future inclusion in the NHI system.

Preparation for broader adoption

Working with a Japanese institution can help a company better understand local clinical practice, physician expectations, patient considerations and the operational requirements for wider use.

An important financial distinction is that the advanced medical treatment component is generally paid for by the patient, while eligible conventional medical services can continue to be covered by NHI. This does not mean that the device company can freely sell or distribute an unapproved product commercially, nor does it guarantee meaningful pre-reimbursement revenue.

Does Advanced Medical Care B Replace a PMDA Clinical Trial?

No. Companies should not view Advanced Medical Care B as a way to avoid a clinical trial that PMDA may require for marketing approval.

The primary purpose of the Advanced Medical Care framework is to evaluate a medical technology in the context of potential future NHI coverage. The resulting clinical information is generated within that framework and is principally relevant to the insurance evaluation process.

This is separate from the regulatory evidence requirements for obtaining marketing approval from PMDA. Although information generated through clinical use may be of interest in subsequent regulatory discussions, its relevance or acceptability for a separate approval application should not be assumed.

Companies should also distinguish Advanced Medical Care B from Japan’s conditional early approval system for certain innovative medical devices. Under qualifying circumstances, including serious unmet medical need and difficulty conducting conventional confirmatory studies, this separate system may allow approval based on limited clinical data together with post-marketing risk management and data collection.

Advanced Medical Care B does not automatically lead to conditional approval, replace PMDA requirements or guarantee that data collected through the framework will satisfy a marketing approval application.

When Might Advanced Medical Care B Not Make Sense?

Despite its potential advantages, the framework will not be appropriate for every medical device.

It may not be worthwhile where:

  • Existing overseas clinical data are likely to be sufficient for Japanese marketing approval.
  • PMDA requires only a relatively small or focused Japanese clinical study.
  • The device can follow a straightforward third-party certification route.
  • There is no suitable Japanese hospital or clinical investigator willing to lead an application.
  • The eligible patient population is too small to justify the effort and cost.
  • Patient out-of-pocket costs or the lack of reimbursement would limit practical adoption.
  • The time and resources required to obtain designation and conduct the evaluation outweigh the potential commercial or clinical benefits.

In some cases, pursuing conventional regulatory approval and reimbursement planning directly may be the more practical route.

What Should Companies Investigate Before Proceeding?

Before investing resources, manufacturers should consider five questions:

  1. Regulatory requirements: What is the applicable Japanese device classification and approval or certification route? Is a Japanese clinical study actually required?
  2. Clinical and reimbursement opportunity: Is there a meaningful clinical need, and is there a realistic prospect of future NHI coverage?
  3. Institutional partner: Is there a Japanese hospital and clinical investigator willing and able to lead the application and meet the facility requirements?
  4. Patient and commercial feasibility: Is the potential patient population sufficient, and would patient out-of-pocket costs allow meaningful use?
  5. Time and resources: Can the company support the institutional application, technical requirements, supply arrangements and evaluation process over the necessary period?

Companies should also clarify responsibilities with the participating institution, including device supply, technical support, data access, publication rights and the handling of any information generated.

Conclusion

Japan’s Advanced Medical Care B system can be worth exploring for selected medical device technologies, particularly where there is a meaningful clinical need, a committed Japanese medical institution and a credible opportunity to progress toward future NHI reimbursement.

However, it is important to understand what the framework does—and what it does not do. It is an institution-led route for defined clinical use and evaluation before reimbursement, not a manufacturer-led application, a substitute for PMDA approval or a guaranteed route to commercial sales.

For international manufacturers, the most sensible starting point is to assess the conventional Japanese regulatory pathway first, then determine whether Advanced Medical Care B offers a meaningful additional opportunity for clinical use and reimbursement evaluation.

Invision Japan supports international medtech companies in assessing Japan market opportunities, understanding regulatory and clinical development considerations, identifying Japanese clinical and commercial partners, and developing practical market-entry strategies. We help companies determine which opportunities are worth investigating before committing significant development resources.

Resources

Ministry of Health, Labour and Welfare (MHLW)

Pharmaceuticals and Medical Devices Agency (PMDA)

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