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Number of newly approved medical devices Japan FY 2014-2020, by category

Number of medical devices newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2020, by category

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Source

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Release date

June 2021

Region

Japan

Survey time period

fiscal year 2014 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

Classification of medical devices according to the source:
1. New medical devices: devices that have a clearly different structure, usage, indications, performance, etc., compared with those for which marketing approval has been granted.
2. Improved medical devices: 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)
3. Generic medical devices: devices that are regarded as substantially equivalent to existing approved 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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