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.

We review our Regulatory Information frequently; please check back often for updates

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.


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

Blue and grey circles used in Licensale logo

For detailed device-specific compliance information for each market, including Japan, to expedite the preparation of your medical device or IVD registration application.


Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

Ready to Get Started?