Jun 25, 2012

The Japanese government is reportedly considering changes to its Pharmaceutical Affairs Law (PAL) that would include separate rules and regulations for medical devices.

According to Medtechinsider.com, the changes were part of a new national strategy devised in early June by the Japanese government council.

Medical devices and pharmaceutical products currently undergo the same registration process in Japan, which industry advocates have argued impedes development of innovative devices in the country. The government’s announcement follows a petition filed in mid 2011 by the Japan Federation of Medical Device Associations arguing for more specific medical device regulations.

One component of regulatory reform under consideration by the government is a fast-track approval process for previously approved devices that have been upgraded. Industry advocates have urged Japanese lawmakers to include this allowance in any future regulatory reform; those efforts appear to have been effective.

PAL revisions, however, will not happen overnight. A bill proposing Japanese medical device approval reforms must first be submitted to the National Diet for approval, followed by adoption and implementation—a process likely to take at least a couple of years.


  • Stewart Eisenhart