丰台角门北京医疗器械三类经营许可证提供人员库房专业快捷包下证
三类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;(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
department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the Class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) data on product risk analysis; (2) technical requirements of the product; (3) product inspection report; and (4) clinical evaluation data; (5) Product specification and label samples; (2) The copy of the pre-approval certificate of enterprise name or the business License issued by the administrative department for industry and commerce; (3) A copy of id card, educational background or professional title certificate of the person in charge of quality management of the enterprise and personal resume; Copy of the id card, educational background or professional title certificate of the quality management personnel; (4) Geographic locatio