U.S. medtech lobbies join forces to blaze trails in China

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A pair of medical technology lobbying groups joined forces on a series of initiatives designed to reduce trade barriers between China and the U.S. and "harmonize international standards for medical devices."

The Medical Imaging & Technology Alliance and the Advanced Medical Technology Assn. last week led a 2-day standards workshop during the U.S.-China Joint Commission on Commerce and Trade Pharmaceuticals & Medical Device Subgroup meeting, according to a press release.

The meeting aimed to "increase the Chinese government’s familiarity with the standard and further expedite their transition process," according to a statement. The workshop was joined by representatives from North and South America as well as Europe and Asia.

China plays a feature role in many medical device companies’ emerging market strategies, including for industry titans Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX).

Last month Medtronic VP VP Simon Li told the Chinese reporters that the world’s largest pure play medical device maker was looking to expand its portfolio in China through a series of mergers and acquisition deals, which will be the centerpiece of its strategy for the People’s Republic.

Late last week the device maker added a managing director from one of Asia’s largest hospital chains to its board of directors, and earlier this month Medtronic launched an international cardiovascular research initiative taking place in 9 emerging markets, including China. 

The lobbying groups convened last week to provide China’s Food & Drug Admin. expertise on IEC 60601-1, the latest edition of the internationally recognized standards for electrical medical equipment.

"The enhanced certainties and efficiencies inherent in China’s adoption of IEC 60601-1 3rd edition will yield significant benefits to patients and manufacturers," MITA executive Director Gail Rodriguez said in prepared remarks.

During the presentation MITA urged Chinese officials to include medical devices in the country’s 2013 manufacturing negotiations with the U.S. and AdvaMed called on the country to consider bumping in vitro diagnostics into a lower-risk category for regulatory purposes.

"China’s transition to the 3rd edition will usher in a more collaborative era of medical standards, driven by safety and international progress in technology," AdvaMed global strategy & analysis executive vice president Ralph Ives added.

If successful, the groups’ efforts in China could also prove a boon for Boston Scientific, Medtronic’s primary competitor in several business units, which has also significantly increased its focus on China.

Last July, the Natick, Mass.-based medical device company announced a 5-year, $150 million plan to expand Chinese commercial operations, including establishing a wholly owned manufacturing site and developing training centers for Chinese health care providers.

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