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平方米，库房使用面积不得少于40平方米。2.经营类代号为三类-6815注射穿刺器械、三类-6845体外循环及液处理设备、三类-6864医用卫生材料及敷料、三类-6865医用缝合材料及粘合剂、三类-6866医用高分子材料及制品的,经营场所使用面积不得少于60平方米，库房使用面积不得少于80平方米。3.从事类代号为
ion certificate, head of the title certificate of geographicallocation premises, warehouse address, plan, building propertycertificate documents or lease agreement (house property rightcertificate) copy 5. The product management catalogue certificate6. 7. The purchase and sale contract, purchase channel note: secondmedical devices for the record for the long term, 6 months beforethe expiration of the new certificate for the filing of Class IImedical devices. The use area should reach at least 60 squaremeters; 2. Personnel requirements: 3 relevant personnel (companyresponsible person, quality responsible person, quality inspectionpersonnel) need to record and hold the certificate; 3, productrequirements: must have the product information in accordance withthe business scope, And issue a certificate; 4. Other relevant lawsand regulations and requirements. Management of three kinds ofmedical equipment, should have adapted to the scale of businesspremises and warehouse 1. Business class code for three-6821medical electronic equipment, three-6846 implant materialartificial organs, three-6863 dental materials, three-6877interventional equipment products, business premises use area shallnot be less than 100 square meters, warehouse use area shall not beless than 40 square meters.2. Business class code for three-6815injection puncture instruments, three-6845 extracorp
