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Japan’s Medical Device market is currently standing at USD 34.24 billion in 2025 and could reach approximately USD 60.7 billion by 2035. For Medical Device (MedTech) companies, this creates strong opportunities, but regulatory complexity, MAH requirements and reimbursement planning remain critical for market access.

Japan Medical Device Market Access: Large Opportunity, High Complexity

Japan remains one of the world’s largest Medical Device markets, supported by an aging population, high healthcare spending and demand for advanced technologies. The market is expected to reach approximately USD 60.7 billion by 2035, reflecting continued growth driven by an aging population, increasing healthcare demand and adoption of advanced medical technologies.

For international MedTech companies, the opportunity is clear. However, Japan is not a simple “registration-only” market. Success depends on aligning product classification, regulatory documentation, local representation, quality requirements, and reimbursement strategy before launching.

Japan MedTech Regulation: PMDA, MHLW and Risk Classification

In Japan, medical devices are primarily regulated under the PMD Act, with oversight divided between two key authorities. The Pharmaceuticals and Medical Devices Agency (PMDA) conducts the technical product reviews and manages post-market safety measures, while the Ministry of Health, Labour and Welfare (MHLW) retains the authority for final administrative decisions and official product approvals.

Japan classifies Medical Devices into four risk classes:

• Class I: notification to PMDA
• Class II: certification by a registered certification body or MHLW approval
• Class III: certification or MHLW approval, depending on standards
• Class IV: MHLW approval

Foreign manufacturers must usually work through a Japanese Marketing Authorization Holder (MAH) or an appointed Japanese manufacturer. This makes local partner selection a strategic market-access decision, not only an administrative step.

Figure 1: Japan Medical Device Market Access

Key Market Access Challenges for MedTech Manufacturers

The main challenges for MedTech companies entering Japan include:

• Correct product classification and route selection
• MAH setup and foreign manufacturer accreditation
• Japanese QMS and technical documentation alignment
• PMDA consultation for complex or innovative devices
• Reimbursement pricing pressure, especially for high-value devices

Reimbursement is particularly important. Japan offers access to a sophisticated healthcare system, but cost-containment measures can affect pricing, especially for imported and innovative Medical Devices.

Outlook for Japan’s MedTech Market

Japan is a highly attractive but demanding market for MedTech manufacturers. Companies with strong clinical evidence, clear regulatory planning, and a well-selected local partner are better positioned to succeed.

Chameleon Pharma Consulting Group (CPC) has over 20 years of experience in supporting Pharma, OTC, Medical Devices, Phyto, and Aesthetic Medicine companies. Having established own offices & local hubs across Latin America, Europe, Asia, the US/Canada, the Middle East, and the CEE/CIS regions is another advantage of CPC. With this local network and expertise gained from 300+ international projects and a team of 25 experts we offer our clients: 

• Business Development, M&A, and Due Diligence
• Market Entry & Expansion: Systematic product and country analysis, market reports
• Strategic Partnering: Identifying local partners, acquisitions, or setting up own offices
• Regulatory & Registration: for drugs, MD, Derma, Aesthetic Medicine, etc.
• Market Authorization & Compliance: Holding MAs, conducting pharmacovigilance
• Quality & Certification: GMP certification, pre-GMP audits

Contact us today for your individual request at service@chameleon-pharma.com!