April 3, 2006
News Release 06-028
Inv. No. 332-474
Contact: Peg O'Laughlin, 202-205-1819


The U.S. International Trade Commission (ITC) has launched a general factfinding investigation regarding certain competitive conditions affecting U.S. trade of medical devices and equipment in principal foreign markets.

The investigation, Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets, (Inv. No. 332-474), was requested by the House Ways and Means Committee in a letter received March 9, 2006.

In its request letter, the Committee noted that a number of important trade issues were raised last September at a hearing held by the Committee on United States-Japan Economic and Trade Relations, including regulatory and reimbursement policies affecting the U.S. medical device and equipment industry in Japan. The Committee asked the ITC, an independent, nonpartisan, factfinding federal agency, to examine closely the regulatory conditions of competition affecting U.S. sales and trade of medical devices and equipment in Japan and other principal foreign markets. The Commission will focus on the main U.S. exports of medical devices and equipment to these markets and compare Japan's regulatory conditions with those of the other major foreign markets for U.S.-made medical devices and equipment. The ITC's investigation will cover the most recent five-year period for which data are available.

As requested, the ITC will also provide an overview of the global market for medical devices and equipment, including production, consumption, and trade; profiles of the medical device and equipment industries in the United States and principal foreign producer countries; an analysis of 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 an examination of 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.

The ITC will provide its report to the Committee by March 9, 2007.

The Commission will hold a public hearing in connection with the investigation at 9:30 a.m. on July 11, 2006. Requests to appear at the public hearing should be filed with the Secretary, United States International Trade Commission, 500 E Street SW, Washington, DC, 20436, and must be received no later than 5:15 p.m. on June 27, 2006.

The ITC also welcomes written submissions for the record. Written submissions (one original and 14 copies) should be addressed to the Secretary of the Commission at the above address and should be filed at the earliest practical date, but no later than 5:15 p.m. on July 25, 2006. All written submissions, except for confidential business information, will be available for public inspection.

Further information on the scope of this investigation and appropriate submissions is available in the ITC's notice of investigation, dated March 3, 2006, which may be obtained from the ITC Internet site (www.usitc.gov) or by contacting the Office of the Secretary at 202-205-2000.

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 subject 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 finding and analyses to the requestor. General factfinding investigations reports are subsequently released to the public, unless they are classified by the requestor for national security reasons.

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