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创可有什么要求呢?徐冰为您详细介绍：一、公司增加一类医疗器械经营范围第一类医疗器械是指，通过常规管理足以保证其安全性、有效性的医疗器械。一类医疗许可证无需办理经营许可证。如果是生产医疗器械，则需要到相关部门备案。二、公司增加二类医疗器械经营范围二类医疗器械备案要求，根据《医疗器械监督管理条例》凡是从事二类医疗器械经营的单位都需要到所在地设区的市级食品药品监督管理部门备案，二类医疗器械是具有中度风险，需要控制管理以保证其安全、有效的医疗器械。如：医用缝合针、血压计、体温计、心电图机、脑电图机、显微镜、针灸针、生化分析系统、助听器、超声消毒设备、不可吸收缝合线等。1.商用性质办公60平，仓储40平2.2名医学专业人员为企业负责人
3.产品经营目录
注：符合以上3点，基本上就可以办理二类医疗器械备案
提供材料
1.二类医疗器械备案申请书
2.营业执照或预先核名通知书
3.法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件
4.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议(附房屋产权证明文件)复印件5.产品经营目录表
6.产品合格证书
7.上家购销合同、进货渠道
vation can have what requirements? Class I medical devices referto the medical devices that are sufficient to ensure their safetyand effectiveness through routine management. Class I medicallicense does not need for a business license. If it is makingmedical devices, it needs to file with the relevant departments.2.Company increase the second kind of medical equipment businessscope of medical device record requirements, according to theregulations on the supervision and administration of medicaldevices who engaged in the second class of medical equipmentbusiness units need to the local municipal food and drugsupervision and administration department for the record, classmedical equipment is a moderate risk, need to control management toensure its safe and effective medical equipment. Such as: medicalsuture needle, sphygmomanometer, thermometer, electrocardiogrammachine, electroencephalography machine, microscope, acupunctureneedle, biochemical analysis system, hearing aid, ultrasonicdisinfection equipment, non-absorbable sutures, etc.1. Commercialoffice 60 ping, storage 40 ping 2.2 medical professionals as thehead of the enterprise 3. Product management catalogue Note: Tomeet the a
