Can Some Medical Devices Skip China's Clinical Trial Mandate?

RAPSRAPS' Latest | 13 February 2015 |  By 

In October 2014, the China Food and Drug Administration (CFDA) implemented its new medical device regulations, including new clinical trial requirements and associated submission processes. To market higher-risk products—those designated as class II or III under the Chinese classification system—the device must undergo a registration process that also may require clinical trials be conducted.

Foreign device manufacturers need to understand that if clinical trials are required, it will certainly impact the time to market entry for their products, says Seth J. Goldenberg, PhD, director of global regulatory strategy for NAMSA, a medical research organization with expertise in China and other global markets. Goldenberg is among three presenters for RAPS' 18 February webcast, New China Medical Device Regulations: Best Practices for Clinical Trials.

In certain situations, class II and III devices may be exempted from clinical trial requirements, or be allowed to undergo modified trials. Device makers may be allowed to "use clinical evidence reports to reduce the size of, or eliminate, clinical trials," says Goldenberg, who will discuss the necessary evidence and documentation in detail during the webcast.

The Chinese regulatory environment is still evolving, and ongoing changes to product standards will have an impact on medical device testing and submission requirements. In the meantime, there are some emerging, essential best practices for anyone involved in marketing devices in China under this new system.

Register for New China Medical Device Regulations: Best Practices for Clinical Trials webcast.


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