Japan to speed arduous medical device approvals with new plan
U.S. device manufacturers hope an "action program" adopted by the Japanese government in December, and tied to increased industry user fees, will significantly speed device approval times in the Japanese market.

Since July 2008, industry representatives have engaged in intensive negotiations with the Japanese government to push for reforms, and the Advanced Medical Technology Association (AdvaMed) said that has now been achieved.

Phil Agress, AdvaMed's vice president for global strategy and analysis, said that Japanese regulators agreed to increase the number of medical device reviewers during the next five years from 35 to 104 and to make significant reforms to regulatory requirements.

The changes will be made in return for more user fee revenue. The fee rates will increase from current levels by a factor of 1.2 to 2.8, depending on the category of product, Agress explained.

The largest fee increase would impact new medical devices in Class IV, the highest-risk category in Japan, he said. Lower-risk devices would see more moderate fee hikes. A specific user fee schedule was expected to be released by the end of December.

Japan plans to increase the number of reviewers on an annual basis in roughly equal increments, adding 13 in fiscal 2009 and 14 in each of the remaining four years, Agress said.

The plan, which takes effect April 1, 2009, also calls for objective performance measures that will be used to evaluate the reviewers semi-annually.

As the ranks of reviewers rise, Japan will also be taking steps to streamline requirements, according to AdvaMed.

As part of the five-year plan, the government will allow a third-party approval for all low-risk Class II products, similar to notified bodies used in the European Union. Currently, only a portion of Class II products can go through the third-party process.

Japan also will reconsider clinical data requirements, allowing a greater portion of products on the market without pre-market human testing, moving closer to the threshold for when clinical trials are necessary in the United States.