Ministry of Health, Labour and Welfare (MHLW)

What is the MHLW? 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 it provides central leadership on healthcare, pharmaceutical regulation, labor standards, social insurance, and more. What does MHLW do? MHLW plays a critical regulatory leadership role across Japan’s health and social systems. It establishes policy and legislative frameworks for healthcare products, including the Pharmaceuticals and Medical Devices Act (PMD Act) under which medical devices are regulated. MHLW retains administrative authority to approve medical devices and oversees classification decisions, while relying on the Pharmaceuticals and Medical Devices Agency (PMDA) to conduct scientific reviews and post-market monitoring. In practice, MHLW typically follows PMDA’s recommendations in granting approvals. Beyond medical devices, MHLW sets standards for quality management systems—through instruments like the Ministerial Ordinance No. 169—and supports regulatory harmonization with international norms such as ISO 13485. Its broader mandate includes overseeing social welfare services, labor policies, health insurance, and national health research, ensuring a comprehensive approach to public well-being.