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, 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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