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大兴磁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

发布时间:2023-12-18        浏览次数:3        返回列表
前言:医疗器械三类,注册公司
大兴磁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

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
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;10、申请材料应完整、清晰、签字,并逐份加盖公章,(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关学历或者职称,质量管理人应在职在岗,不得在其他单位兼职;(二)具有与经营规模和经营范围相适应的相对独立的经营场所;(三)具有与经营规模和经营范围相适的储存条件,包括具有符合医疗器械产品特性要求的储存设施、设备;(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、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;(5)企业产品质量管理制度文件及储存设施、设备目录。(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企

he 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) product risk analysis data; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; 10, the application materials shall be complete, clear and signed with official seal; (1) two quality management agencies or quality management personnel compatible with the business scale and business scope. The quality management personnel shall have relevant professional qualifications or professional titles recognized by the state, Quality managers should be on the job, Do not take part-time jobs in other units; (2) having a relatively independent business site commensurate with the scale and scope of operation; (3) having storage conditions suitable for the scale and scope of business, Including storage facilities and equipment that meet the characteristic requirements of medical devices; (4) A product quality control system shall be established and improved, Including procurement, purchase acceptance, storage, warehouse review, quality tracking system and adverse event reporting system; (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 medical device business enterprise license, Signed by the legal representative or affixed with the 


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