Device lag of new medical devices Japan FY 2011-2020

Delay in the timing for new medical devices to be approved in Japan compared to the US from fiscal year 2011 to 2020

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Release date

December 2021

Region

Japan

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

*Development lag refers to the median difference between the timing of applications for new medical devices filed in Japan and the timing of applications for those devices that were filed in the US.
**Approval lag refers to the median difference between the review period for new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in each fiscal year and the average review period for those devices approved by the Food and Drug Administration (FDA) in the US in the corresponding calendar year.
***Device lag = development lag + approval lag

New medical devices have a clearly different structure, usage, indications, performance, etc., compared with those for which marketing approval has been granted.

Figures prior to fiscal 2016 come from the previous reporting.

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