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、进货渠道注：二类医疗器械备案有效期为长期，到期前6个月到所在地设区的市级食品药品监督管理部门换发二类医疗器械备案新凭证三、公司增加三类医疗器械经营范围三类医疗器械经营许可证要求：1、场地要求：必须是办公性质，使用面积要Zui少达到60平方米;2、人员要求：需要
d to ensure their safe and effective medical devices. Such as:medical suture needle, sphygmomanometer, thermometer,electrocardiogram machine, electroencephalography machine,microscope, acupuncture needle, biochemical analysis system,hearing aid, ultrasonic disinfection equipment, non-absorbablesutures, etc.1. Commercial office 60 ping, storage 40 ping 2.2medical professionals as the head of the enterprise 3. Note: Meetthe above 3 points, Basically can deal with two medical devices forthe record to provide material 1. 2 class medical devices for therecord application 2. Business license or nuclear name notice inadvance 3. Certificate of the legal representative, enterprise,quality, education, head of the title certificate of 4. Businesslocation, warehouse address, plan, building property certificatedocuments or lease agreement (house property documents) copy 5.Product management directory table 6. product qualificationcertificate 7. Home sales contract, purchase channel note: secondme
