MEDICAL DEVICE REGISTRATION AND APPROVAL IN Japan

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
Last update: January 2024

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 3-16 months, depending on classification.

LICENSE VALIDITY: Licenses issued in Japan expire after five years. Licenses for lower classes do not have expiry date.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

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

 

Other Central & East Asia Countries: Afghanistan, IndiaJapanKazakhstanKyrgyzstanNepalRussiaSouth KoreaSri LankaTaiwanTajikistanUzbekistan

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