Japan: newly approved generic medical devices, by year of submission

532 generic medical devices that were submitted in the fiscal year 2020 were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan so far, down from 1,032 approved generic products applied in fiscal 2012. 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 approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2011 to 2020, by year of submission

Year of submission	Number of approved products
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Release date

June 2021

More information

Region

Japan

Survey time period

fiscal year 2011 to 2020; the Japanese fiscal year starts on April 1 of the stated year and ends on March 31 of the following year

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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