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Number of newly approved medical devices Japan FY 2009-2018, by year of submission

16 medical devices that were submitted in the fiscal year 2018 were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan so far, down from 95 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 medical devices newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2009 to 2018, by year of submission

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Release date

November 2019



Survey time period

fiscal year 2009 to 2018; the Japanese fiscal year starts on April 1 of the stated year and ends on March 31 of the following year

Special properties

number of approved medical devices by the year of submission

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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Statistics on "Medical device industry in Japan"

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