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、首先要网登,申请医疗器械经营许可证填写公司相关资料并提交。
二、提交完毕后接下来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)
ipal, secondary copy and official seal; 4. Warehouse address materials; Procedures for handling the business license of Class III medical devices 1. First of all, to network access, apply for the medical device business license to fill in the company's relevant information and submit. 2. After the submission, the next step needs to prepare the following materials to submit the materials on site 1.) Application Form for Medical Device Business License 2) Original copy of the business License) (photocopy) 3) Copy of the identity certificate, educational background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality; 4.) Description of organization structure and department setting 5) The geographical location map, floor plan, house property right certificate of the business site or the copy of the house lease certificate issued by the house lease, which belongs to the third party logistics of district medical