On May 19, 2015, the China Food and Drug Administration (CFDA) posted details of the requirements for Clinical Evaluation Reports (CERS). The guidance is applicable for the evaluation of Class II and III devices for registration in China.
The key issue is whether the new product to be registered in China is “basically equivalent” to an already registered predicate product. “Basically equivalent” means similar in basic principle, structural composition, manufacturing material, performance requirements, among other requirements.
To date, several CERs have been submitted to the CFDA, without feedback as of yet. Whether such CERs will help foreign companies avoid local clinical trials in China for device registration is still not clear.