In Japan, medical device regulatory approval alone does not guarantee your product will enter the market. Before physicians or clinicians can use newly approved devices for insured care, products must receive a reimbursement determination from Japan’s Ministry of Health, Labour and Welfare (MHLW) following deliberation and endorsement by the Central Social Insurance Medical Council, known as Chuikyo.

That reimbursement path is rigorous, complex, and interconnected with regulatory submission. Partnering with a Designated Marketing Authorization Holder (DMAH) or Marketing Authorization Holder (MAH) that has intimate knowledge of medical device market entry is a critical first step toward bringing your product successfully into the large and vital Japanese market.

Japan’s healthcare and medical device reimbursement systems

Japan offers universal health coverage, which ensures every citizen, as well as eligible foreign residents, has covered access to medical care. Mandatory coverage for adults under age 75 falls into two main tracks:

• Employees’ Health Insurance for salaried workers and their dependents
• National Health Insurance for self-employed, unemployed, and retired individuals, including foreign nationals who live in Japan for more than three months

A separate system covers adults age 75 and older.

Patients are responsible for a 10% to 30% co-pay depending on age and income level. The public health insurance system covers the rest.

Much like in the United States, the medical reimbursement system decides which medical services and technologies the insurance system covers. The process to receive that determination, however, is much different from U.S. reimbursement requirements.

The Japanese government operates a single national fee schedule that sets payment for medical procedures and for individually reimbursed medical devices. Chuikyo, an advisory council to the Minister of Health and Labour and Welfare, deliberates on and endorses new coverage and pricing decisions based on recommendations from its Insurance Medical Materials Expert Organization (Hozaisen), a subcommittee of Chuikyo.

The reimbursement process for medical device manufacturers

Reimbursement planning begins well before regulatory submission, while the formal reimbursement application follows regulatory approval. Upon that approval, manufacturers submit a reimbursement application along with clinical and/or economic evidence and supporting documentation, proposing one of several application categories. The category determines how the device will be priced and how long listing takes.

Many implantable and single-use devices, such as pacemakers and artificial joints, fall into the special treatment materials (STM) category. STMs fall into one or more of 1,314 functional subcategories. Pacemakers, for example, feature 10 distinct functional subcategories.

STM reimbursement prices are set separately from procedure and technical fees. Non-STM devices, such as imaging equipment, are covered within the procedure fee. In-Vitro Diagnostics have their own path. Pricing for a new STM is generally decided by comparing the new technology with comparable listed technologies.

With application categories in mind, the manufacturer, working through its DMAH or MAH, prepares a reimbursement dossier.

Regulatory and reimbursement integration

Reimbursement strategy must be developed starting from the early stages of development and introduction. An integrated approach considers factors such as regulatory strategy, insurance coverage, reimbursement, pricing, and business strategy. All these functions play a role in product valuation.

In Japan, an integrated approach is essential: Medical device manufacturers must formulate and present product launch strategies that consider not only regulatory requirements, but also market needs and the insurance coverage pathway.

How IQVIA MedTech helps manufacturers enter the Japanese market

IQVIA MedTech helps medical device companies navigate the complexities of entering and expanding in Japan. Through Vorpal Technologies K.K., our Tokyo-based team provides local expertise across regulatory strategy, PMDA/MHLW requirements, reimbursement, and Designated Marketing Authorization Holder (DMAH) services.

For companies without an established presence in Japan, language barriers and unfamiliar regulatory and reimbursement requirements can complicate market entry. IQVIA MedTech combines Vorpal Technologies K.K.’s bilingual, in-market expertise with broader global capabilities to help clients navigate these requirements with confidence.

For example, a surgical robotics company partnered with IQVIA MedTech to pursue regulatory approval and reimbursement for its novel Aquablation therapy in Japan. Our team helped secure a new reimbursement category listing for the device.

By combining Vorpal Technologies K.K.’s Japan-based expertise with IQVIA MedTech’s broader capabilities, we help manufacturers develop integrated strategies spanning regulatory submissions, reimbursement, and ongoing DMAH responsibilities.

Ready to expand into Japan? Connect with IQVIA MedTech to discuss your market-entry strategy.