办理二类备案您需要提供:
1.法人身份信息;
2.质量员身份信息;
3.公司营业执照正副本以及公章;
4.库房地址材料;
三类医疗器械经营许可证办理流程
一、要网登,申请医疗器械经营许可证填写公司相关资料并提交。
二、提交完毕后需要准备以下资料去现场提交材料
1.)《医疗器械经营许可证申请表》
2)《营业执照正副本原件)(复印件)
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.)组织机构与部门设置说明
5)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由房屋租赁所出具的房屋租赁凭证复印件,属仓储委托区疗器械第三方物流的,提供委托合同(复印件1份,).
6)经营设施、设备目录
7)经营质量管理制度、工作程序等文件目录;
8)办理医疗器械经营许可证企业已安装的计算机信息管理系统基本情况介绍和功能说明,
9)凡申请企业申报材料时,办理人员不是法定代表人或企业负责人本人,企业应当提交《授权委托书》 (原件1份)
ative, the person in charge of the enterprise and the person incharge of quality; 4.) Description of organization structure anddepartment setting 5) The geographical location map, floor plan,house property right certificate of the business site or the copyof the house lease certificate issued by the house lease, whichbelongs to the third party logistics of district medical equipment,provide the entrustment contract (1 copy,). 6) Catalogue ofoperating facilities and equipment 7) Catalogue of operationquality management system, working procedures and other documents;8) Basic information introduction and function description of thecomputer information management system installed by the enterprisedealing with the medical device business license, 9) When applyingfor the application materials of the enterprise, the handlingperson is not the legal representative or th