Mar 30, 2011

The Japan Federation of Medical Device Associations (JFMDA) has begun pushing for regulations specifically targeting the medical device industry ahead of plans next year to revise the country’s Pharmaceutical Affairs Law (PAL).

According to, JFMDA chairman Kazuo Ogino held a press conference March 25 to argue that the PAL’s current iteration has bogged down development of innovative medical technologies in Japan because the law treats devices and pharmaceutical products in the same regulatory fashion.

Although the Japanese Health, Labor and Welfare Ministry has given no indication that it plans to include new rules targeting only medical devices in the 2012 PAL revision, the JFMDA will lobby for such requirements as a fast-track approval system for upgraded products that have already gone through the device approval process once.

A formal petition will be filed at some point with the ministry, according to Ogino.


  • Stewart Eisenhart