PMDA

Pharmaceuticals and Medical Devices Agency

PMDA 🇯🇵 Japan National Active
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About

PMDA regulates medical devices in Japan under the PMD Act. It conducts premarket reviews (Shonin approval), GMP inspections, and post-market safety measures. Japan uses the MDSAP framework for manufacturer audits.

Regulatory Details

Regulatory FrameworkPharmaceutical and Medical Device Act (PMD Act)
Device ClassificationClass I, Class II, Class III, Class IV
Jurisdiction TypeNational
Country🇯🇵 Japan
StatusActive

Contact Information

Country🇯🇵 Japan
AddressShin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
Phone+81-3-3506-9541

Official Website

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