Japan: approved new medical devices by year of submission

32 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 99 approved products applied in fiscal 2014. The PMDA functions as a regulatory agency for pharmaceutical products and medical devices, and works together with the health ministry in Japan.

Number of new 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

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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

Figures include the number of approved new medical devices and improved medical devices.
New medical devices have a clearly different structure, usage, indications, performance, etc., compared with those for which marketing approval has been granted.
Improved medical devices are devices that do not fall under “new medical devices” or “generic medical devices,” and are not so novel as to be subject to re-examination, nor are substantially equivalent to existing medical devices in terms of structure, usage, indications, performance, etc. (as defined under the PMD. Act).

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