top of page
Abstract art of Hand of Business man Holding the virtual hologram future system.  Innovati
Deviceology - The Japana Market Access People

Deviceology excels in guiding clients through the multifaceted and promising landscape of Japan's Medical Devices industry. Drawing on our deep-rooted expertise in international regulations and ISO standards, particularly ISO 13485 for quality management systems, we offer an array of services to ease your market entry.

Our seasoned professionals offer indispensable advice on adhering to the rigorous regulatory framework governed by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. We also provide comprehensive insights into the Japanese Pharmaceutical Affairs Law (PAL) and the Medical Device Single Audit Program (MDSAP), facilitating a more streamlined approval process for manufacturers from MDSAP-participating countries.

Japan's Medical Devices market is noteworthy for its sophistication and growth potential. With a healthcare expenditure that is among the highest in Asia and a rapidly ageing population, Japan offers a fertile ground for medical device innovation and adoption. Our market intelligence services are finely tuned to identify these lucrative opportunities, with a focus on emerging sectors such as robotics, cardiology, and geriatric care.

Our end-to-end solutions, ranging from advanced market analysis to market entry programmes, are designed to not only meet international and Japanese regulatory standards but also to align with Japan's unique healthcare policies and reimbursement systems.

By entering into a collaboration with Deviceology, clients can expect a seamless, compliant, and strategically advantageous foray into Japan's highly rewarding Medical Devices market.

Market Data

The medical devices market in Japan is forecasted to continuously grow between 2023 and 2028, with an increase of 1.2 trillion JPY (+27.34 percent).

By 2028, the market is estimated to reach a new peak of 5.5 trillion JPY.

  • Cardiology Devices

  • Diagnostic Imaging

  • Orthopedic Devices:

  • Ophthalmic Devices: 

  • General & Plastic Surgery Devices

  • Other Medical Devices:

  • In fiscal 2021, Japan's healthcare expenditures reached a record high of ¥44.2 trillion, which is approximately $296.14 billion USD

  • The spending on hospitalization increased to ¥17.6 trillion, approximately $118.12 billion USD

  • Outpatient services, home visits, and other medical treatments rose to ¥15.3 trillion, approximately $102.51 billion USD

  • Average medical expenses per capita increased to ¥352,000, approximately $2,358.40 USD 


Opportunities in the Japanese market include the development of advanced diagnostic and treatment devices, particularly for an aging population. There is also a focus on wearable technology and AI-integrated devices.

Medical Devices Market Valuation

Key Market Segments

Healthcare Expenditure

Market Dynamics

Aging Population: Japan's high proportion of elderly citizens is driving demand for medical devices that cater to age-related health issues, prompting government investment in healthcare infrastructure.

Technological Advancements: Japan's leadership in technology is influencing its medical devices market, with innovations like robotics, 3D printing, and telemedicine improving efficiency and patient outcomes.

Government Initiatives: A focus on AI and wearable technology, supported by government incentives and partnerships, is creating new growth opportunities in the sector.

Contact us to discuss your access requirements for Japan's Medical Devices market

Deviceology - The Market Access People

Thanks for submitting!

bottom of page