PMDA (Pharmaceuticals and Medical Devices Agency)

The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory authority responsible for ensuring the safety, quality, and efficacy of pharmaceuticals, medical devices, and other healthcare products before they are marketed or distributed 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 device registration review for class II, III, and IV devices, QMS inspections, and formal consultations. Fees vary depending on classification, predicate status/JMDN code application, and clinical evidence requirements.

What regulations does the PMDA enforce?  

Japan's primary medical device regulation is the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, commonly called the PMD Act. Ordinance #169 is the regulation on quality management system requirements for medical devices.

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.  

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Website: PMDA
Address: Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
Email: Contact form

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