北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
朝阳十里河北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

(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;办理三类医疗器械经营许可证的办理流程:

(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等;

(五)应当具备与其经

applicant shall submit the application materials to the relevant departments; (2) the relevant departments shall accept the application of the applicant's application; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for product filing of Class I medical devices and application for product registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) technical requirements of the product; (3) product inspection report; procedures for handling the business license of Class III medical devices: (4) The product quality management system shall be established and improved, including procurement, purchase and acceptance inspection, storage, warehouse delivery review, quality tracking system and the reporting system of adverse events; (5) It shall have its own experience


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