什么是医疗器械经营许可证?在北京想要办理都需要哪些流程?
医疗器械经营许可证是一种特殊的许可证件,由国家食品药品监督管理总局审批颁发,要求是:从事医疗器械经营活动的企业必须符合相关标准和条件。医疗器械经营许可证是一种特殊的许可证,因此,办理医疗器械经营许可证需要满足以下几个条件:
(1)具有与经营的医疗器械相适应的场所、环境、设施设备;
(2)具有与经营的医疗器械相适应的专业指导、技术培训和售后服务的能力,或者约定由相关机构提供技术支持;
(3)符合下列要求之一:
得医疗器械经营许可证。一、申请三类医疗器械经营备案凭证所需的申请材料:
1.三类医疗器械经营备案表;
2.组织机构营业执照及代码证复印件;
3.法定代表人、企业负责人、质量负责人身份明、学历或职称证明复印件;
4.组织机构和部门设置说明;
5.经营范围、经营方式说明;
6.经营场所、仓库地址地理位置图、平面图、房屋产权证明或房屋租赁出具的租赁证明复印件;
7.经营设施,设备目录;
8.经营质量管理制度、工作程序等文件目录;
9.经办人授权证
办理医疗器械三类经营许可证要完成以下流程:
1、经营范围要有“销售医疗器械”
2、网申提交医疗器械材料
3、药监窗口提交三类材料(携带原件),等待通知核查
4、领取医疗器械许可证(若有二类,提交材料,当天下备案单)
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