海淀田村北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱周期短Zui快7天下证

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,

ense of Class III medical devices 1. First of all, to networkaccess, apply for the medical device business license to fill inthe company's relevant information and submit. 2. After thesubmission, the next step needs to prepare the following materialsto submit the materials on site 1.) Application Form for MedicalDevice Business License 2) Original copy of business License)(photocopy) 3) Copy of the identity certificate, educationalbackground or professional title certificate of the legalrepresentative, the person in charge of the enterprise and theperson in charge of quality; 4.) Description of organizationstructure and department setting 5) The geographical location map,floor plan, house property right certificate of the business siteor the copy of the house lease certificate issued by thehouse