西城新街口北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件库房速度快专业方便

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)

10）申报材料真实性的自我保证声明,包括申请材料目录和企业对材料作出如有虚假承担法律责任的承诺(原件1份).

三、现场提交成功后约去现场勘察，现场需提交材料

1）岗位职责

2）工作程序

3）公司制度

4）供应商档案

5）培训记录

6）新法律法规

7）员工档案等

现场核查成功后一周内就可以拿证了。

tity certificate, educational background or professional titlecertificate of the legal representative, the person in charge ofthe enterprise and the person in charge of ; 4.) descriptionof organization structure and department setting 5) thegeographical location map, floor plan, house property rightcertificate of the business site or the copy of the house leasecertificate issued by the house lease, which belongs to the thirdparty logistics of district medical e, provide theentrustment contract (1 copy,). 6) catalogue of operatingfacilities and e 7) catalogue of operation management system, working procedures and other documents; 8) basicinformation introduction and function description of the computerinformation management system installed by the enterprise dealingwith the medical device business license, 9) when applying for theapplication materials of the enterprise, the handling person is notthe legal representative or the person in charge of the enterprise,the enterprise shall submit the power of attorney (1 original) 10)self-guarantee statement of the authenticity of the applicationmaterials, including the catalogue of the application materials andthe enterprise's commitment to bear legal liability if there is anyfalse material (1 original). 3. after successful site submission,go to the site for investigation and submit materials on site 1)job responsibilities 2) working procedures 3) company system 4)supplier files 5) training records 6) new laws and regulati