AdvaMed Applauds Chinese Commitment to Streamline Medical Device Regulatory Requirements

FOR IMMEDIATE RELEASE September 17, 2008

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) welcomed an announcement by Chinese officials that will streamline regulatory requirements for medical devices exported to China.

At a meeting of the U.S.-China Joint Commission on Commerce and Trade (JCCT), which concluded yesterday in Yorba Linda, Calif., the two agencies involved in medical device regulation in China jointly announced they would no longer have separate testing, reporting and inspection requirements for medical device manufacturers wishing to enter the Chinese market. The Agency for Quality Supervision, Inspection and Quarantine and the State Food and Drug Administration also announced that separate requirement fees would be eliminated in favor of a single fee, the agencies announced.

“We applaud the Chinese government for taking this important step to reduce redundant regulatory requirements that do nothing to promote the public health of the Chinese people and only serve to delay availability of innovative new products,” said Ralph Ives, AdvaMed Executive Vice President, Global Strategy & Analysis. “With the support of the U.S. government, AdvaMed has been working for several years to eliminate redundant tests and inspections in China. We would like to express our deep appreciation to JCCT co-chairs U.S. Commerce Secretary Carlos M. Gutierrez and U.S. Trade Representative Susan C. Schwab for their leadership on this issue and to the staff of both agencies for their hard work.”

Additionally, China’s National Development Reform Commission agreed to seek input from the U.S. Government and relevant stakeholders on its revised draft medical device pricing policy. China’s proposed pricing policy could limit the access of Chinese consumers to high-quality imported medical devices. China also agreed to hold discussions with the U.S. Government and relevant stakeholders regarding China’s medical device procurement policies to ensure that tendering processes are fair and transparent and that the quality and innovation of medical devices are given adequate consideration in purchasing decisions.

“AdvaMed is pleased with the Chinese Government’s commitment to launch a dialogue on pricing and tendering issues,” said Ives. “As China reforms its health care system, properly reflecting the full value of technology will be important to ensuring patient access to the most advanced medical devices.”
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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.  regularation

China to Streamline Medical Device Exports
by Barbara Kram, Editor

WASHINGTON, D.C. - The Advanced Medical Technology Association (AdvaMed) welcomed an announcement by Chinese officials that will streamline regulatory requirements for medical devices exported to China.

At a meeting of the U.S.-China Joint Commission on Commerce and Trade (JCCT), which concluded yesterday in Yorba Linda, Calif., the two agencies involved in medical device regulation in China jointly announced they would no longer have separate testing, reporting and inspection requirements for medical device manufacturers wishing to enter the Chinese market. The Agency for Quality Supervision, Inspection and Quarantine and the State Food and Drug Administration also announced that separate requirement fees would be eliminated in favor of a single fee, the agencies announced.

"We applaud the Chinese government for taking this important step to reduce redundant regulatory requirements that do nothing to promote the public health of the Chinese people and only serve to delay availability of innovative new products," said Ralph Ives, AdvaMed Executive Vice president, Global Strategy & Analysis. "With the support of the U.S. government, AdvaMed has been working for several years to eliminate redundant tests and inspections in China. We would like to express our deep appreciation to JCCT co-chairs U.S. Commerce Secretary Carlos M. Gutierrez and U.S. Trade Representative Susan C. Schwab for their leadership on this issue and to the staff of both agencies for their hard work."

Additionally, China's National Development Reform Commission agreed to seek input from the U.S. Government and relevant stakeholders on its revised draft medical device pricing policy. China's proposed pricing policy could limit the access of Chinese consumers to high-quality imported medical devices. China also agreed to hold discussions with the U.S. Government and relevant stakeholders regarding China's medical device procurement policies to ensure that tendering processes are fair and transparent and that the quality and innovation of medical devices are given adequate consideration in purchasing decisions.

"AdvaMed is pleased with the Chinese Government's commitment to launch a dialogue on pricing and tendering issues," said Ives. "As China reforms its health care system, properly reflecting the full value of technology will be important to ensuring patient access to the most advanced medical devices."

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.