March 28, 2007
News Release 07-033
Inv. No. 332-474
Contact: Peg O'Laughlin, 202-205-1819


Average regulatory approval times for new medical devices in Japan were longer than those in other principal global markets, and that may adversely affect U.S. medical device and equipment firms, reports the U.S. International Trade Commission (ITC) in its publication Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets.

The ITC, an independent, nonpartisan, factfinding federal agency, examined the competitive conditions, including regulatory conditions, affecting the medical device industries of the United States, the European Union (EU), and Japan at the request of the U.S. House of Representatives Committee on Ways and Means.

As requested, the ITC report provides an overview of the global market for medical devices and equipment, including production, consumption, and trade; profiles the medical device and equipment industries in the United States and principal foreign producer countries, namely the EU and Japan; analyzes U.S. trade in medical devices and equipment with major competitor countries, including a description of trade practices, regulatory measures such as product approvals, and government and private expenditures on medical research; and examines bilateral and multilateral trade agreements that have addressed regulatory issues in major foreign markets, including Japan's, and the implications for the U.S. medical device and equipment industry. Highlights of the report follow.

Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets (Investigation No. 332-474, USITC Publication 3909, March 2007) will be available on the ITC's Internet site at /publications/docs/pubs/332/pub3909.pdf. A CD-ROM of the report may be requested by calling 202-205-2000 or by writing the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Requests may also be faxed to 202-205-2104.

ITC general factfinding investigations, such as this one, cover matters related to tariffs or trade and are generally conducted at the request of the U.S. Trade Representative, the Senate Committee on Finance, or the House Committee on Ways and Means. The resulting reports convey the Commission's objective findings and independent analyses on the subjects investigated. The Commission makes no recommendations on policy or other matters in its general factfinding reports. Upon completion of each investigation, the ITC submits its findings and analyses to the requester. General factfinding investigation reports are subsequently released to the public unless they are classified by the requester for national security reasons.

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