第1类:

是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。比如手术刀、手术剪、纱布绷带、医用冰袋、听诊器等。

第2类:

是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。比如我们日常生活中常见的体温计、血压计、心电图仪、雾化器等。

第3类:

是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。比如常见的销售xinguan实际检测盒、隐形眼镜、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等。

医疗器械经营许可证现为后置审批，有效期为5年。有效期届满需要延续的，依照有关行政许可的法律规定办理延续手续。

一、三类医疗器知械许可证注册所需材料

1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明;

2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;

3、质量管理文件等;

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