Japan MHLW and PMDA: Who Does What?

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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.