Report: Japanese Regulatory System Hurts Innovative Devicemakers

Japan has the "slowest, least transparent and most difficult regulatory system" of the major medical device markets, hurting developers of innovative, advanced-technology devices, a new report from the International Trade Commission (ITC) says.

U.S. devicemakers are the leading developers and exporters of these products and may be disproportionately affected, the ITC added.

The study examined competitive conditions, particularly regulatory conditions, affecting U.S. sales and trade of medical devices in Japan and other principal foreign markets from 2001 to 2005.

Firms specializing in innovative products are more adversely affected by regulatory delays and other "unique costs" of the Japanese approval system because of the shorter product life cycles -- as short as 18 months -- and more rigorous regulatory evaluation of these products compared with those of less-advanced technologies, the report said.

Total new medical device applications from U.S. companies submitted for Japanese review decreased from 132 in 2003 to only eight in 2005, the ITC found. U.S. medical industry officials cited "burdensome applications and an unpredictable approval process," as reasons for the decline, the report said.

The report, "Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Markets," can be seen at hotdocs.usitc.gov/docs/pubs/332/pub3909.pdf ( http://hotdocs.usitc.gov/docs/pubs/332/pub3909.pdf ).

( http://www.fdanews.com/ddl/34_15/ )