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：需要有3名相关人员(公司负责人、质量负责人、质量检查人员)的备案并且持有证书;3、产品要求：必须要有合乎业务范围的产品信息，并出具证书;4、其他相关法律法规要求。经营三类类医疗器械的，应具备与经营规模相适应的经营场所和库房1.经营类代号为三类-6821医用电子仪器设备、三类-6846植入材料人工器官、三类-6863口腔科材料、三类-6877介入器材产品的，经营场所使用面积不得少于100平方
g, 2.2 medical professionals are the head of the enterprise 3.Note: conforming to the above 3 points, Basically can deal with twomedical devices for the record to provide material 1. 2 classmedical devices for the record application 2. Business license ornuclear name notice in advance 3. Head of the legal representative,enterprise, quality, identity certificate, certificate of educationor title certificate of 4. Warehouse address location map, plan,building property right documents or lease agreement (houseproperty right documents) copy 5. Product management directorytable 6. product qualification certificate 7. Home sales contract,purchase channel note: second medical devices for the record forthe long term, 6 months before the expiration of the newcertificate for the filing of Class II medical devices. Use an areaof at least 60 square meters; 2. Personnel requirements: 3 relevantpersonnel (company responsible person, quality responsible person,quality inspection personnel) need to record and hold thecertificate; 3, product requirements: must have the productinformation in
