Number of approved generic medical devices Japan FY 2013-2022, by year of submiss

Published by
Catharina Klein,
Jan 9, 2024
441 generic medical devices that were submitted in the fiscal year 2022 were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan so far. PMDA functions as a regulatory agency for pharmaceutical products and medical devices, working with Japan's health ministry.

Number of generic medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2013 to 2022, by year of submission

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Release date

September 2023

Region

Japan

Survey time period

fiscal year 2013 to 2022; 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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