Number of newly approved medical devices Japan FY 2014-2022, by application type

In the fiscal year 2022, over one thousand medical devices were newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, of which 364 were from new applications. The PMDA functions as a regulatory agency for pharmaceutical products and medical devices and works together with the Ministry of Health, Labour and Welfare in Japan.

在2022财年，日本药品医疗器械局（PMDA）新批准了一千余件医疗设备，其中364件为全新申请。药品医疗器械局作为药品及医疗器械的监管机构，与日本厚生劳动省协同工作。