四、办理医疗器械三类,交件需要哪些材料?
1. 营业执照副本原件,公章
2. 法人、企业负责人、质量管理人身份证跟毕业证原件及复印件、职称证明
3. 办公室房产证、租赁合同复印件;
4. 库房房产证、租赁合同复印件;(委托三方储存的,需要三方物流资质复印件、库房的产权证明和租赁合同复印件、物流服务协议和质量保证协议复印件;)
五、验收之前需要注意的事项:
房子:
1.面积达到要求。
2. 办公室设备设施齐全(办公桌椅、文件柜、电脑、打印机、固定网络等办公设备)
3.门牌号、门牌logo
4.现场与平面图一致;
5.不能有家居用品;
6.库房要是空置状态
7.摆放地拍或者货架,温湿度计,粘鼠板,灭火器,空调等
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Copy of the office property ownership certificate and leasecontract; Copy of the property ownership certificate and leasecontract; (for the three parties, copy of the logisticsqualification, property right certificate and lease contract, copyof logistics service agreement and quality assurance agreement;) 5.Note before acceptance: house: 1. The area meets the requirements.2. Complete office equipment and facilities (office desks andchairs, file cabinets, computers, printers, fixed network and otheroffice equipment) 3. Door plate number and door plate logo 4. Thesite is consistent with the floor plan; 5. No household items; 6.If the warehouse is empty 7. Put floor photos or shelves,hygrometer, sticky mouse board, fire extinguisher, airconditioning, etc About the handling of medical devices is notclear, yo