U.S. International Trade Commission to Investigate Medical Device Market in Japan

The U.S. International Trade Commission will be conducting a fact-finding investigation into the competitive conditions in Japan and other foreign markets for medical devices and equipment. The investigation will focus on comparing the regulatory environment in Japan with those of other countries that are main markets for U.S.-manufactured medical devices.

The International Trade Commission will also analyze any bilateral and multilateral trade agreements that have previously addressed regulatory issues to look at the implication of these agreements for the U.S. medical device and equipment industry. Japan regulatory approval process for new medical devices is notoriously slow, and U.S. medical device companies have complained that Japanese regulations are too costly and burdensome.

The investigation was initiated at the request of the House Ways and Means Committee and will be completed by March 9, 2007. There will also be a public hearing held in July 2006. The medical device market in Japan was also mentioned in the United States Trade Representative’s 2006 National Trade Estimate Report on Foreign Trade Barriers with regard to expanding market access.