关键词: font-size:medium, ">医疗器械不良事件监测； 第Ⅰ类医疗器械； 假冒； 调查分析； 警示

Abstract: 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.

Key words: font-size:medium, ">Medical device adverse event monitoring；Class I medical device；Counterfeit；Investigation and analysis； Warning