Medical Device Registration and Approval in Japan

General country-specific regulatory information is provided on this page for medical device registration and approval in Japan. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Japan, free of charge, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Japan

 REGULATORY AUTHORITY: Medical devices are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare (MHLW).

CLASSIFICATION SYSTEM: Devices are classified according to risk into Classes I, II, III and IV.

TIMEFRAME: The registration process ranges from 8-16 months, depending on classification.

LICENSE VALIDITY: Licenses issued in Japan expire after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

ADDITIONAL INFORMATION: An application of Foreign Manufacturers Accreditation (FMA) is required in addition to the product license.

Last updated on February 9 2015

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