MHLW (Ministry of Health, Labour and Welfare)
The Ministry of Health, Labour and Welfare (MHLW) is a cabinet-level entity within the Japanese government responsible for public health, labor policy, and welfare services.
Japan · MHLW
Japan MHLW and PMDA: Who Does What?
MHLW is Japan’s Ministry of Health, Labour and Welfare.
Open the video guideWhat you’ll learn
- MHLW is Japan’s Ministry of Health, Labour and Welfare.
- Devices outside the eligible certification scope may require approval through MHLW following PMDA review.
- For an overseas manufacturer, plan the Japanese marketing authorization holder arrangement.
Read the video transcript
Planning a medical device launch in Japan? Two names often appear together: MHLW and PMDA. Understanding their different roles helps you ask the right questions from the start.
MHLW is Japan’s Ministry of Health, Labour and Welfare. It holds administrative authority for device approvals. PMDA performs scientific reviews and important post-market safety work.
The route starts with the device’s intended purpose and classification. Review the actual product and its evidence, rather than assuming every device needs the same kind of application.
Japan has four device classes. Class one generally follows notification. For certain class two and class three devices, an applicable certification standard can open a certification route.
Devices outside the eligible certification scope may require approval through MHLW following PMDA review. Class four devices follow the approval pathway. Do not equate class two with automatic certification.
A product label, intended-use statement and technical file should describe the same device. Check the scope carefully before deciding that a Japanese certification standard covers your product.
For an overseas manufacturer, plan the Japanese marketing authorization holder arrangement. Quality-system requirements and the evidence for safety and performance also belong in the early project plan.
Start by separating the institution from the pathway. Our MHLW glossary explains the ministry’s role and connects you with PMDA and Japan’s market-access guidance.
Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.
The Ministry of Health, Labour and Welfare (MHLW) is a cabinet-level ministry within the Japanese government responsible for public health, labor policy, and welfare services. It was formed in 2001 through the merger of the former Ministry of Health and Welfare and the Ministry of Labour, and plays a critical regulatory leadership role across Japan’s health and social systems.
MHLW establishes policy and legislative frameworks for healthcare products, including the Pharmaceuticals and Medical Devices Act (PMD Act) under which medical devices in Japan are regulated. MHLW retains administrative authority to approve medical devices and oversees classification decisions, but the Pharmaceuticals and Medical Devices Agency (PMDA) conducts scientific reviews and post-market monitoring. In practice, MHLW usually follows PMDA’s recommendations when granting approvals. MHLW sets standards for quality management systems through Ministerial Ordinance No. 169 and supports regulatory harmonization with international norms such as ISO 13485 and through participation in the Medical Device Single Audit Program (MDSAP).
When was the MHLW established?
The MHLW was established by a merger of the Ministry of Health and Welfare and the Ministry of Labour on January 6, 2001, as part of a government program for reorganizing government ministries. The Ministry of Health and Welfare was originally established in 1938.
Does the MHLW charge fees?
Japan's medical device approval, certification, QMS, and consultation routes can involve user fees. PMDA charges for the approval reviews, conformity assessments, and formal consultations it performs; registered certification bodies charge separately for certification routes. The applicable route and fee depend on device class, certification standards, application category, and evidence requirements. See PMDA's official approval and certification overview.
How do I contact the MHLW?
The MHLW's general switchboard can be reached by phone at +81-(0)3-5253-1111, and general written inquiries may be submitted to www-admin@mhlw.go.jp. However, inquiries related to medical device registration or regulatory requirements are best directed to the PMDA. You can also contact MEDISO (MEDical Innovation Support Office), an MHLW initiative, for regulatory advice.
Website: MHLW
Address: 1-2-2 Kasumigaseki Chiyoda-ku Tokyo, 100-8916 Japan
Phone: 03-5253-1111
Email: www-admin@mhlw.go.jp
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