朝阳豆各庄北京医疗器械三类经营许可证可全包代办专业快捷包下证

发布日期 :2023-12-19 05:36 编号:12978339 发布IP:221.222.177.225
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北京星期三企业管理咨询有限公司业务部  
医疗器械三类
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医疗器械二类
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马胜辉(先生)
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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;

(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)应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。

(六)具有与经营的医疗器械相适应的质量管理制度。

其次,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

t departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices and application for registration of medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report and (4) clinical evaluation data; (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 the ability of technical training and after-sales service suitable with the medical devices it operates. (6) It shall have a quality management system suitable for the medical devices in operation. Secondly, the operating enterprise should know what information it needs to prepare for the business license of three types of medical equipment. (1) Submit the application form for the license of the medical device trading enterprise, signed by the legal representative or affix the official seal of the enterprise; (2) The copy of the pre-approval certificate of 



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