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.
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