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China Indefinitely Postpones Medical Device Import Regulation

by Barbara Kram, Editor | December 11, 2007
China's
Administration of
Quality Supervision,
Inspection, and
Quarantine (AQSIQ).
WASHINGTON, D.C. - AdvaMed President and CEO Stephen J. Ubl released the following statement regarding an announcement by China's Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) and the inspection of U.S. manufactured medical devices:

"AdvaMed welcomes the recent announcement by AQSIQ to indefinitely postpone a regulation known as Decree 95 that would have required inspections of up to 100 percent of all medical device shipments at the port of importation. Such an effort would have seriously delayed patient access to lifesaving and life-enhancing medical technologies.

"We look forward to working with AQSIQ to craft regulations to ensure import safety without creating delays in patient access to medical devices or unnecessarily disrupting our strong trading relationship."

For a U.S.-China trade update from the U.S. Department of Commerce, go to:U.S. Commerce News Room