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日前,一起因经营标签不符合规定的案件处理过程与结果,值得广大食药监管执法人员深思,其案件起于某市食药监管执法人员在位于该市的医疗器械经营单位甲公司进行监督检查时,发现该公司在2014年11月进口了一台机电类医疗器械乙产品准备用于销售,该产品于2013年取得第二类医疗器械注册证书,注册产品标准显示某应用部分为BF型,但检查乙产品该应用部分却发现中英文标签分别标示B型和BF型符号。对该公司违法行为的认定和处理问题上,
A few days ago, due to the operation of the label does not meet the requirements of the case handling process and the results, it is worth pondering over the majority of food and drug regulatory law enforcement officers, the case of food and drug regulatory law enforcement officers in a city in the city’s medical equipment company A supervisory inspection , The company found that the company imported a set of electromechanical medical device B products ready for sale in November 2014. The product obtained the second category of medical device registration certificate in 2013. The registered product standard shows that the application part is of the BF type, However, the application of B products but found that the Chinese and English labels were labeled type B and type BF symbols. On the company’s illegal act of identification and handling issues,