• buy 
• sell $
• about
• My DOTmed 

WASHINGTON, D.C. - The Advanced Medical Technology Association (AdvaMed) welcomes a series of commitments aimed at streamlining the regulatory process for medical devices announced by China during a meeting of the U.S.-China Joint Commission on Commerce and Trade (JCCT) in Hangzhou, China this week.

In an effort to avoid duplicative or redundant product recall regulations, China announced that responsibilities relating to product recalls will be retained by the Ministry of Health and the State Food and Drug Administration. Moving forward China will no longer require companies to register their products in the country of export as a condition of registration in China. Specifically, China agreed to accept a product registration document issued by any foreign country regardless of its exporting origin, country of manufacture or legal manufacture to satisfy China's prior approval requirements.

China also announced it will not automatically require clinical trials in China for certain risk classes of devices. Instead, China will adopt a risk-based approach and will consider the use of results from clinical trials conducted outside of China.

"AdvaMed applauds China for committing to measures we believe will streamline the medical device regulatory process and provide the Chinese people with access to the most innovative and advanced medical technologies in a timely manner," said Ralph Ives, executive vice president, global strategy & analysis for AdvaMed.

Additionally, if a medical device manufacturer demonstrates compliance with international standards and provides sound scientific evidence, China will consider an exemption from its requirement to test product samples in Chinese test labs prior to approval. The Chinese government also pledged to strive to implement regulations, rules, and notices that are consistent with guidance documents for medical devices issued by the Global Harmonization Task Force and the Asia Harmonization Working Party.

"With the support of the U.S. government, AdvaMed has been working for several years to eliminate redundancies in the Chinese regulatory process," said Ives. "The clinical trial requirement previously outlined by China could have affected all but 2 percent of U.S. medical device exports to China, putting at risk more than $1 billion of exports. Altogether, these measures will save medical device manufacturers hundreds of millions of dollars of potential costs related to doing business in China. We would like to express our deep appreciation to JCCT co-chairs U. S. Trade Representative Ron Kirk, U.S. Commerce Secretary Gary Locke, and Chinese Vice Premier Wang Qishan for their leadership on these issues and to the staff on both sides for their hard work."

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.