通过医疗器械不良事件监测信息发现假冒销售行为的警示

Warning of Counterfeiting Sales Behavior Through Medical Device Adverse Event Monitoring Information

通过我市医疗器械不良事件监测工作中发现的一起Ⅰ类医疗器械假冒产品销售行为,对生产企业、经营企业、使用单位进行产品调查核实过程中,发现生产企业、经营企业、使用单位在医疗器械的生产、经营、使用中均存在一定的问题,特别是对Ⅰ类医疗器械经营企业的监管存在一定空白。针对此案例以次充好的产品假冒销售行为,新旧《医疗器械监督管理条例》《医疗器械经营监督管理办法》等相关法律法规均未有相关处罚条款。为更好地规范医疗器械经营行为,保护消费者合法使用权益,辖区市场监督管理局依据《中华人民共和国反不正当竞争法》相关条款和自由裁量执行标准对此起假冒销售行为进行了处罚。本研究以该案例为戒,以期为完善医疗器械日常监管提供参考。

Based on the analysis of sale activities of counterfeit products of class I medical device found in the monitoring of adverse events of medical device in Nanchang city,certain problems in the production,operation and use of medical device were found during the product investigation and verification of production enterprises,business enterprises and users,especially in the supervision of class I medical device operating enterprises.For this case,the fake sales of inferior products,there are no relevant punishment provisions in the old and new Regulations on the supervision and administration of medical device&Measures for supervision and administration of medical device operation up to now.In order to effectively regulate the business behavior of medical device and protect the legitimate use rights and interests of consumers,the Administration for Market Regulation under this jurisdiction punished this fake selling behavior according to the relevant provisions of the Anti-unfair Competition Law of the People′s Republic of China and the discretionary implementation standards.Taking this case as a warning,which provide reference for improving the daily supervision of medical device.