哈尔滨工商注册、商标代理注册

医药医疗器械审批medicine, medical machines evaluation:

 二维码 494

二类医疗器械经营许可证申请资料

medicalmachines management license application material:

【购买】联系电话:18645127155


1、《医疗器械经营企业许可证申请表》一式2份,

医疗器械经营企业许可证电子申报文件一份。

工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》副本原件和1份复印件。

申请报告。(包括企业人员情况介绍、经营规模、经营范围等内容)

4、经营场地、仓库场所的证明文件,包括房产证明或租赁协议和出租方的房产证明的复印件。(注:如属国览医疗器械城入驻商户的经营企业需提供统一仓储和统一质量管理机构相关文件)

5、经营场所、仓库布局平面图。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租赁协议(附房屋产权证明文件)复印件

拟办法定负责人、企业负责人、质量管理人的身份证、学历证明或职称证明的复印件及个人简历。

7、技术人员一览表及学历、职称证书复印件。

8、经营质量管理规范文件目录1份,包括采购、验收、入库、出库、质量跟踪、用户反馈、不良事件监测和质量事故报告制度等文件;

9、企业已安装的产品购、销、存的信息管理系统,打印信息管理系统首页一份。

10、仓储设施设备目录。 11、质量管理人员在岗自我保证声明和申请材料真实性的自我保证声明1份,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;

12、凡申请企业申报材料时,办理人员不是法定代表人或负责人本人,企业应当提交《授权委托书》1份。

13、申请《医疗器械经营企业许可证》确认书

1. “medical machinesmanagement license application form” 2

”medical machinesmanagement license permission” electric application document, 1

The “enterprises namepre-check notice” or the “commercial management license”

issued by the Commercialauthorization management department, their original document and their copies.

the application report.(itincludes the enterprise working staffs’ information, management scale,management scope and so on)

4. the management place,warehouse proof document, they include the real estate certification or therental agreement and the lender’s real estate certification’s copy.(notice: ifthe enterprise is the enterprise that entered the national medical machinescastle then, it need to provide the warehouse document and the qualitymanagement institution’s document.)

5. management place,warehouse map. Management place, warehouse address and its geography map, flatmap, real estate certification or the rental agreement(with the real estateownership certification) copy.

We can help the enterpriseto apply for enterprise owner, quality manager’s personal certification, studydegree certification or position certification. We need their personalcertification, study degree certification or position certification’s copy andtheir CV.

7. engineers list, theirstudy degree, working position certification copy.

8, management quality regulationdocument list 1, it contains: purchase, check, enter the warehouse, go out fromthe warehouse, quality follow, customers’ feedback, the bad quality audit andthe quality report document;

9, the information managementsystem of the purchasing, selling and storing that is installed by theenterprise, print the first page of the information management system.

10, warehouse facilitieslist.

11. quality managementstaffs’ guarantee notice and the guarantee notice of the truth of theapplication  each for 1 including theapplication list and the notice by the enterprise which declare that if theapplication is fake, the enterprise will take the responsibility.

12, if the staff whoapplied is not the representative of the enterprise or the owner, then, theenterprise should provide the power authorizing document for 1.  

13. the confirmation forthe application of the “medical machine management enterprise certification”



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