门头沟潭柘寺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

经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。

(1)提交医疗器械经营企业许可证申请表，法定代表人签字或加盖企业公章；

(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件；

(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历；质量管理人员的身份证、学历或者职称证明复印件；

(4)经营场所、仓库的地理位置图、平面图（注明面积）、房屋产权证明或者租赁协议复印件；

(5)企业产品质量管理制度文件及储存设施、设备目录。

(6）对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时，企业具备的运输装备、仓储设施设备情况表。

、第三类医疗器械经营许可证怎么办理

（1）申请人提交申请资料到相关部门；

（2）相关部门受理申请人的申请；

（3）到实际场地进行勘察以及对产品进行审核；

（4）准予颁发三类医疗器械许可证。

at information to prepare for the three types of medicalequipment business license. (1) Submit the application form for thelicense of the medical device operating enterprise, and make thelegal representative sign or affix the official seal of theenterprise; (2) The copy of the pre-approval certificate ofenterprise name or the business License issued by theadministrative department for industry and commerce; (3) Copy of idcard, educational background or professional title certificate andpersonal resume of the person in charge of quality management ofthe enterprise; photocopy of id card, educational background orprofessional title certificate of the quality management personnel;(4) A copy of the geographical location plan, floor plan(indicating the area), the property right certificate or the leaseagreement;