Overview

Japan Market Size for Medical Devices Market Size = local production + imports – exports. Data Source: Annual Pharmaceutical Production Statistics, Ministry of Health, Labour and Welfare (MHLW) U.S. Commercial Service Japan (CS Japan) estimated 2024 import and export data, and 2025 figures.

Japan’s market for medical devices continues to be among the world’s largest.  Given Japan’s aging population and the increasing number of patients with chronic and lifestyle diseases, the market is expected to continue to expand.  Japan’s Ministry of Health, Labour and Welfare (MHLW) data show that the Japanese market for medical devices in 2024 was $32 billion.  Fitch Solutions estimates that Japan’s medical device market will exhibit a compound annual growth rate (“CAGR”) of 4.4% from 2024 to 2029.

Many U.S. medical device companies – including larger companies such as GE Healthcare, Johnson & Johnson, Abbott, Edwards Lifesciences, Medtronic, Stryker, Zimmer, and 3M – have subsidiaries in Japan.  The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD), an industry association for Japanese subsidiaries of U.S.-based corporations engaged in the manufacture and sale of medical devices and in-vitro diagnostics, currently has over 60 member companies in Japan.  In addition, many U.S. medical devices are sold through Japanese importers and distributors.  According to AMDD, U.S. products’ share of Japan’s medical device market is significantly higher than the percentage reflected in official statistics.  AMDD estimates that U.S. origin products may account for as much as 60 percent of Japan’s medical device market, including production in Japan by U.S. companies.

While the market for U.S. medical devices in Japan remains strong, U.S. firms face challenges with reimbursement pricing due to GOJ efforts to contain overall healthcare costs that continue to increase given Japan’s aging population and low birthrate.  Under these circumstances, the GOJ has taken various measures to cut healthcare spending.  Concerning medical devices, one such measure is the Foreign Average Price (FAP) Rule.  The FAP is the average list price of specific medical devices in the United States, the United Kingdom, France, Germany, and Australia. Since Japan implemented the FAP Rule in 2002, the GOJ has continued to revise application of the rule to effectively reduce medical device reimbursement prices, including prices of innovative U.S. medical devices.
 

Leading Sub-sectors 

Digital Health

Japan is working to improve its regulatory process for Software as a Medical Device (SaMD), an area where it still lags globally. In September 2023, MHLW launched “DASH for SaMD 2,” expanding on its 2020 strategy to streamline commercialization and enhance predictability. A key feature is a two-stage approval system, allowing limited initial use based on test performance, followed by full approval with real-world evidence. In January 2024, PMDA’s draft mid-term plan (JFY 2024–2028) set a six-month review goal for priority SaMD cases and proposed a new SaMD review department and consultation category. While these steps aim to boost domestic innovation, U.S. firms with advanced SaMD offerings may also benefit.

Caregiving Technology 

As Japan’s population declines, the demand for caregiving continues to rise, with a projected shortfall of 570,000 caregivers by 2040. To address this, the government is promoting the use of caregiving robots and ICT devices—collectively termed “caregiving technology”—to improve care quality, reduce staff burden, and support elderly independence. In June 2024, the GOJ released its “Priority Areas for the Use of Caregiving Technology” policy, targeting areas such as transfer, mobility, toileting, and bathing support, as well as monitoring, functional training, and dementia care. With growing need and government support, Japan offers strong business potential for U.S. companies with advanced caregiving solutions.

Opportunities 

Japan continues to be an important market for innovative U.S. medical device companies as Japan’s medical device market remains heavily dependent on imports, especially advanced medical devices. The U.S. continues to be the top exporter in Japan’s medical device market, and U.S. companies excel in therapeutic devices and also holds a fair share in diagnostic devices. 

Japan’s aging population drives demand for advanced medical technologies. Japan’s relatively prosperous seniors have increasingly high expectations for improved quality of life in their later years. Opportunities in Japan exist for innovative new medical technologies and therapies that alleviate pain, complement lost functions, and improve quality of life, especially in the disease areas identified in the previously referenced survey. Specific medical devices that are likely to see increased sales potential are minimally invasive medical devices, as well as medical technologies and diagnostics utilizing Internet of Things (“IoT”) and Artificial Intelligence (“AI”).  Other medical devices that will likely enjoy increased market opportunities are those associated with telemedicine, in-home care, self-care, and preventive care. 

In addition, the Japanese medical device market is supported by the following factors that underpin market opportunities:

• High healthcare expenditure: Japan spends about 10% of its GDP on healthcare, one of the highest levels among OECD countries. The government’s medical expense subsidies and insurance systems provide an environment where patients can easily access advanced medical care.
   
• Stable regulatory environment: Japan’s medical device regulations are aligned with global standards, with a strong emphasis on quality, safety, and efficacy. In recent years, the approval process has been expedited, making it easier to bring innovative products to the market.
   
• Government support and policies: The Japanese government recognizes the medical device industry as an important sector and has introduced regulatory easing and support measures, particularly in the areas of software as medical devices (SaMD).
   
• Research capability: There are numerous research institutions, universities, and medical device companies, that are actively engaged in R&D.
   
• Legal framework: Japan has a strong legal framework to protect intellectual property (IP).

Resources

Government of Japan Agencies

• Ministry of Health, Labor and Welfare (“MHLW”)

• Pharmaceutical and Medical Device Agency (“PMDA”)

• Ministry of Economy, Trade and Industry (“METI”) 

   

Medical Device Organizations 

• American Medical Devices and Diagnostics Manufacturers’ Association (“AMDD”)

• The Japan Federation of Medical Devices Associations (“JFMDA”)

• Japan Bioindustry Association (“JBA”)

Trade Shows

• Medical Japan
  Spring (Osaka) / Fall (Tokyo)

• CPhI Japan
  April (Tokyo)

• MEDTEC Japan
  April (Tokyo)

• International Technical Exhibition of Medical Imaging (ITEM)
  April (Yokohama)

• INTERPHEX Week JAPAN
  June (Tokyo)

• Bio Japan
  October (Yokohama)
   

Commercial Service Japan

For additional information about Japan’s medical device business sector, please contact Commercial Service Japan (“CS Japan”) at Office.Tokyo@trade.gov, Mr. Hiroyuki Hanawa at Hiroyuki.Hanawa@trade.gov.