Japan: approved new medical devices by year of submission

Eight medical devices that were submitted in the fiscal year 2022 were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan so far. The PMDA functions as a regulatory agency for pharmaceutical products and medical devices, and works with Japan's health ministry.

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

Year of submission	Number of approved products
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Release date

September 2023

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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

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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