Device lag of new medical devices Japan FY 2011-2020

*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.