Japan Software as a Medical Device Market is expected to reach US$ 96.20 million by 2033 | Major Companies - Japan Medical Device Corporation, Nipro Corporation, Micron, Inc.

Market Size and Growth:

The Japan Software as a Medical Device Market size reached US$ 19.55 million in 2024 and is expected to reach US$ 96.20 million by 2033, growing at a CAGR of 17.3% during the forecast period 2025-2033.

The Japan Software as a Medical Device Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving global market.

Get a Free Sample PDF Of This Report (Get Higher Priority for Corporate Email ID): https://datamintelligence.com/download-sample/japan-software-as-a-medical-device-market?sz

The Japan Software as a Medical Device (SaMD) Market refers to the sector involving software products intended for medical purposes, such as diagnosis, monitoring, or treatment, without being part of a physical device. It encompasses AI-driven applications, mobile health solutions, and clinical decision support tools that enhance patient care, streamline healthcare workflows, and improve diagnostic accuracy in Japan's healthcare ecosystem.

Recent Key Developments of Japan:

✅ November 2025: Fujitsu Limited launched an AI-based SaMD for early detection of diabetic retinopathy, securing PMDA approval and integration into national screening programs.​

✅ October 2025: NEC Corporation expanded its remote monitoring software platform with enhanced predictive analytics for heart failure patients, partnering with major hospitals.​

✅ September 2025: Canon Medical Systems introduced a cloud-based radiology SaMD using deep learning reconstruction to improve image quality and diagnostic accuracy.​

Recent Key Developments of Europe:

✅ November 2025: European Commission adopted Decision (EU) 2025/2371, declaring key EUDAMED modules fully operational, enabling mandatory registration for SaMD and other devices starting May 2026.​

✅ November 2025: WHO Europe intervened on AI safety in SaMD, prompting calls to delay AI Act enforcement overlapping with MDR to ease dual compliance burdens for manufacturers.​

✅ October 2025: MedTech Europe issued a position paper advocating risk-based PMCF approaches for low-risk SaMD under MDR, addressing concerns over excessive clinical investigation burdens.​

List of the Key Players in the Japan Software as a Medical Device Market:

Japan Medical Device Corporation
Nipro Corporation
Micron, Inc
Olympus Medical Systems
Anaut Inc

Speak to Our Analyst and Get Customization in the report as per your requirements: https://datamintelligence.com/customize/japan-software-as-a-medical-device-market?sz

This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

Segments Covered in the Japan Software as a Medical Device Market:

By Application: Disease Management, Diagnostics, Treatment Monitoring, Predictive Health Analytics, Others.

By Indication: Diabetes, Mental Health, Oncology, Cardiovascular, Respiratory Conditions, Others.

Looking For Full Report? Get it Here: https://www.datamintelligence.com/buy-now-page?report=japan-software-as-a-medical-device-market

Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Japan Software as a Medical Device market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Japan Software as a Medical Device Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Japan Software as a Medical Device market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Japan Software as a Medical Device Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

Unlock 360° Market Intelligence with DataM Subscription Services: https://www.datamintelligence.com/reports-subscription

People Also Ask:

◆ How big is the Japan Software as a Medical Device Market in 2025?
◆ What is the projected growth rate of the Japan Software as a Medical Device Market through 2033?
◆ Who are the key players in the Japan Software as a Medical Device Market?
◆ Which region is expected to dominate the industry during the forecast period?

Contact Us -
Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -
DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.
Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

This release was published on openPR.