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Number of newly approved generic medical devices Japan FY 2009-2018

558 generic medical devices that were submitted in the fiscal year 2018 were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan so far, down from 1,038 approved generic products applied in fiscal 2009. PMDA functions as a regulatory agency for pharmaceutical products and medical devices, working together with the health ministry in Japan.

Number of generic medical devices newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2009 to 2018

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Release date

November 2019



Survey time period

fiscal year 2009 to 2018; the Japanese fiscal year starts on April 1 of the stated year and ends on March 31 of the following year

Special properties

number of approved medical devices by the year of submission

Supplementary notes

Generic medical devices are devices that are regarded as substantially equivalent to existing approved medical devices in terms of structure, usage, indications, performance, etc. (as defined under the PMD Act).

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Statistics on "Medical device industry in Japan"

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