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Number of approved new medical devices Japan FY 2011-2020, by year of submission

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

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Release date

June 2021



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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