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海淀温泉北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷

医疗器械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下:
(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。
2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;
(四)临床评价资料;
(五)产品说明书以及标签样稿;办理三类医疗器械经营许可证的办理流程:

(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

lations on Supervision and Administration of Medical Devices for the filing of Class I medical devices products and the application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; the process for handling the business license of Class III medical devices: (3) a copy of the id card, educational background or professional title certificate and personal resume of the quality management manager of the enterprise; a copy of the ID card, educational background or professional title certificate of the quality management personnel; (4) Business premises and warehouses

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