Japan: newly approved medical devices by application type

In the fiscal year 2022, over one thousand medical devices were newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, of which 364 were from new applications. The PMDA functions as a regulatory agency for pharmaceutical products and medical devices and works together with the Ministry of Health, Labour and Welfare in Japan.

Number of medical devices newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2022, by application type

Characteristic	New	Partial change
-	-	-
-	-	-
-	-	-
-	-	-
-	-	-
-	-	-
-	-	-
-	-	-
-	-	-

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Release date

September 2023

More information

Region

Japan

Survey time period

fiscal year 2014 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

Partial changes of products include:
1. addition, change, or deletion of purposes of use or effects.
2. changes concerning the inactivation or removal of pathogenic factors.
3. any changes that could potentially affect the quality, efficacy, or safety of a product.
4. changes in the form or structure that could potentially affect the nature of the product.

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