PMDA (Pharmaceuticals and Medical Devices Agency)

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