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Is there a MDR (Medical Device Reporting) equivalent in China ?

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BJMQA

#1
Does the CFDA have the equivalent of a MDR? We have a customer, based in China, who only sells in China, and has reported a defect back to us. We are US based. The defect could lead to extended surgery times if encountered and not detected prior to surgery. By FDA's definition this is a reportable event, but I can not find device regulations, in english, which call out the requirements for reporting this to the CFDA. Also, our customer said they are not filing this as a complaint because the complainant did not file an official complaint. Is this how a complaint should be handled in China? Any help is much appreciated.
 
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