第1類:

是風險程度低，實行常規(guī)管理可以保證其安全、有效的醫(yī)療器械。比如手術刀、手術剪、紗布繃帶、醫(yī)用冰袋、聽診器等。

第2類:

是具有中度風險，需要嚴格控制管理以保證其安全、有效的醫(yī)療器械。比如我們日常生活中常見的體溫計、血壓計、心電圖儀、霧化器等。

第3類:

是具有較高風險，需要采取特別措施嚴格控制管理以保證其安全、有效的醫(yī)療器械。比如常見的銷售xinguan實際檢測盒、隱形眼鏡、注射器、靜脈留置針、心臟支架、呼吸機、CT、核磁共振等。

醫(yī)療器械經營許可證現(xiàn)為后置審批，有效期為5年。有效期屆滿需要延續(xù)的，依照有關行政許可的法律規(guī)定辦理延續(xù)手續(xù)。

一、三類醫(yī)療器知械許可證注冊所需材料

1、企業(yè)名稱與經營范圍，注冊資本及股東出資比例，股東等身份證明;

2、醫(yī)療器械產品注冊證書、供應商營業(yè)執(zhí)照、許可證及授權書;

3、質量管理文件等;

calpel, surgical scissors, gauze bandages, medical ice packs, stethoscope, etc. Category 2: It is a medical device with moderate risk and needs strict control and management to ensure its safety and effectiveness. For example, in our daily life, the common thermometer, sphygmomanometer, electrocardiogram instrument, atomizer and so on. Category 3: It is a medical device with high risk and needs to take special measures to strictly control and manage it to ensure its safety and effectiveness. For example, the common sales of COV actual detection box, contact lenses, syringe, intravenous indwelling needle, heart stents, ventilators, CT, nuclear magnetic resonance, etc. The medical device business license is now po