根据Zui新法规要求:
6840体外诊断试剂含冷链:办公室30平,库房40平,冷链20立方米
剩下所有产品都是:办公室30平,库房40平
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
关于办理医疗器械还有不清楚的,可以随时联系我,十余年经营专注于办理医疗器械,北京各区政策十分了解,经验十足,为您解决各种疑难问题!!!
copy of the logistics qualification, property rightcertificate and lease contract, copy of logistics service agreementand quality assurance agreement;) 5. Note before acceptance: house:1. The area meets the requirements. 2. Complete office equipmentand facilities (office desks and chairs, file cabinets, computers,printers, fixed network and other office equipment) 3. Door platenumber and door plate logo 4. The site is consistent with the floorplan; 5. No household items; 6. If the warehouse is empty 7. Putfloor photos or shelves, hygrometer, sticky mouse board, fireextinguishers, air conditioning, etc About the handling of medicaldevices is not clear, you can contact me at any time, more than tenyears of business focus on the