China Reduces Trade Barriers, Harmonizes Device Standards

The Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) are reducing trade barriers and harmonizing medical device standards with China.

The announcement comes after the organizations led the Chinese State FDA and other industry representatives in a two-day workshop on the IEC-60601-third edition, the internationally recognized safety standard for electrical medical equipment.

The workshop, which took place during the U.S.-China Joint Commission on Commerce and Trade Pharmaceuticals, aimed to increase the Chinese government’s familiarity with the standard and further expedite their process. Speakers from North and South America, Europe, and Asia represented the global medical device industry.

“China’s transition to the third edition will usher in a more collaborative era of medical standards, driven by safety and international progress in technology,” says Ralph Ives, AdvaMed executive vice president for global strategy and analysis.

According to a statement from AdvaMed, the officials from the SFDA say they appreciated the opportunity to meet on the issues, and affirmed that the country’s system has been modeled on international best practices.

During the meeting, MITA called on Chinese officials to include medical devices in the 2013 US – China remanufacturing dialogue, and it was announced that SFDA recently published a list of down classified X-ray products as part of their 2011 JCCT commitments.

The statement also describes the benefits of moving certain in-vitro diagnostic devices into lower-risk categories for regulatory purposes.

“Currently, China classifies many in-vitro diagnostics as higher-risk devices than other major medical device markets, which slows patient access to the most advanced diagnostic technologies,” says Nancy Travis, AdvaMed vice president of global strategy and analysis.

The statement emphasizes the importance of following Global Harmonization Task Force guidance that recommends acceptance of a broad range of clinical evidence in the registration process and to avoid mandating clinical trials for any group of medical devices. SFDA officials say they welcome these suggestions as well as U.S. industry’s proposal to conduct an information exchange program on clinical evidence.

“We have made incredible progress over the past three days that will benefit members of both our associations, the larger global medical device manufacturing community and most importantly, patients who benefit from our technologies,” says Davey Han, MITA’s China representative.