Japan: newly approved medical devices by category

In the fiscal year 2020, 1,119 medical devices were newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, of which 769 were generic medical devices. 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 2014 to 2020, by category

Characteristic	New medical devices	Improved medical devices (with clinical data)	Improved medical devices (without clinical data)	Generic medical devices	Re-manufacturing single-use devices (R-SUD)
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-	-	-	-	-	-
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Release date

June 2021

More information

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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