PMDA (Pharmaceuticals and Medical Devices Agency)
The Pharmaceuticals and Medical Devices Agency (PMDA) is an independent institution under Japan’s Ministry of Health, Labour and Welfare (MHLW), responsible for the scientific evaluation and safety oversight of pharmaceuticals, medical devices, regenerative medicines, and related health products.
Video guide
Japan PMDA: Device Routes and Review Times
A video guide to Japan's PMDA, device classes, notification, certification, ministry approval and review timelines.
Open video pageTranscript (English)
What is Japan's PMDA? Since 2004, it has reviewed medicines and medical devices, and tracked their safety after they launch. But it does not grant the approval. PMDA publishes its review clock, and how it performs. In fiscal year 2025, its scorecard covered 38 new medical devices approved on standard review. 34 of them were approved within its target: 14 months from application. The route depends on the class. Class I is a notification to PMDA. Class II and III devices with certification standards go to a registered certification body. The rest, and every Class IV device, need ministry approval after PMDA review. And one point that often gets mixed up. PMDA does the scientific review and the safety monitoring. The approval decision belongs to the Ministry of Health, Labour and Welfare. Start with three things. One: confirm your device class and its route. Two: appoint a marketing authorization holder based in Japan. Three: prepare the application forms in Japanese, not English. Pick the route before the dossier. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s scientific review and safety agency for pharmaceuticals, medical devices, and other healthcare products regulated in Japan. It operates in close collaboration with the Ministry of Health, Labour and Welfare (MHLW) and plays a central role in public health through scientific evaluation, ongoing surveillance, and regulatory enforcement of health products.
While the MHLW issues product approvals, the PMDA is responsible for conducting the technical and scientific evaluations that support product approvals, as well as post-market safety monitoring. The agency conducts rigorous scientific assessments to confirm that products meet established standards prior to market entry. It also oversees post-market surveillance, monitoring adverse events, recalls, and emerging safety concerns to ensure products remain safe throughout their lifecycle.
When was the PMDA established?
The PMDA was established on April 1, 2004, under the Law for the Pharmaceuticals and Medical Devices Agency.
Does the PMDA charge fees?
Yes. PMDA charges fees for approval reviews, QMS conformity assessments, and formal consultations. Not every Class II or III device follows PMDA approval review: devices covered by certification standards may be certified by a registered certification body, while other Class II and III devices and Class IV devices require MHLW approval supported by PMDA review. Check the current route and fee category for the specific device.
What regulatory framework does PMDA support?
Japan's primary medical device law is the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, commonly called the PMD Act. MHLW Ministerial Ordinance No. 169 establishes medical device quality-management-system requirements. See PMDA's official approval and certification overview for the division of responsibilities and class-based routes.
How do I contact the PMDA?
The PMDA's English-language contact form is the best way to contact them. The agency typically takes about 15 working days to respond.
Website: PMDA
Address: Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
Email: Contact form
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