Japan Unveils Plan to Speed Up Medical Device Approval

 A new program in Japan that will begin in April is aimed at speeding up review procedures for medical devices in the country.

“The action program is fairly comprehensive, and it covers almost all of the major areas that have created unnecessary delays in the approval process,” said Phil Agress, vice president for global strategy at AdvaMed, a group that advocates for medical technology. 

The initiative, which takes effect April 1, will mandate an increase in user fees to make changes, including increasing the number of product evaluators from 35 to 104 over five years. The fee rates will increase from current levels by a factor of 1.2 to 2.8, depending on the category of product, according to Agress.

The largest fee increase would impact new medical devices in Class IV, the highest-risk category in Japan, and lower-risk devices would see more moderate fee hikes.

The plan also calls for objective performance measures that will be used to evaluate the reviewers semi-annually.

“They will be publicly accountable, so we’ll be able to see whether the benefits that all of these measures are intended to produce actually accrue or not,” he said.