Based on PMDA’s five-year improvement program, the user fee system for device evaluation also is new as of April 1 (see chart on page 51).
To cope with the device lag, PMDA is going to increase the number of medical device reviewers from 35 at present to 104 within the next five years.
A three-track evaluation system will be introduced.
Depending on the level of novelty, medical devices shall be classified into three levels, including new medical devices, improved medical devices and “me-too” medical devices (those with a predicate technology already on the market), with each evaluated by a specialized team. The new evaluation system will simplify the application forms (including partial changes) and may shorten the evaluation process for minor modifications such as changing a raw material in a device that does not affect any function or efficacy of the device.
The user fee will vary depending upon device category. The user fee for general medical devices hasn’t changed much, however the maximum increase will impact new concept medical devices requiring clinical data.
For that category, the user fee is 246 percent more than it used to be. This, obviously, is burdensome for medical device applicants.
To ensure products are assigned to the correct category for approval, the PMDA recommends preliminary consultation with the agency.
Consultation fees, however, also have increased. For example, the pre-application consultation fee has risen 151.3 percent. This also is quite burdensome for industry. Despite such dramatic fee increases, if evaluation times become shorter, it will be worthwhile for the industry.
PMDA has set the target of shortening evaluation periods in the next five years for new medical devices from 21 months at present to 14 months, improved medical devices from 16 months to 10 months, and me-too devices from the current eight months to four months.
These fees certainly will be difficult for for small to midsize companies and startups. Many are concerned that such a barrier to entry would keep innovative small device firms from entering the Japanese market, and patients would lose the opportunity to be treated by the most advanced medical technology.
Reduced fees for smaller companies (similar to the device user fee program in the United States) had been expected, but was not part of the new plan. In order to encourage small companies and entrepreneurs, alternative measures are expected for the future.