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
北京石景山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

(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;
6、公司章程、股东会决议等;7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章,如无公章,则须有法定代表人本人签字或签章。9、凡申请材料需提交复印件的,申请人(单位)须在复印件上注明“此复印件与原件相符”字样或者文字说明,注明日期,加盖单位公章;个人申请的须签字或签章。10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A4纸打印,复印使用A4纸,按照申请材料目录顺序装订成册。

investigate the actual site and review the product; (4) grant the issuance of a class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for filing and applying for the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; 6, the articles of association and the resolution of the shareholders' meeting; 7. the enterprise shall establish quality management files or forms of medical devices according to its actual conditions.8. The self-guarantee statement of the authenticity of the application materials shall be signed by the legal representative and affixed with the official seal of the enterprise. If there is no official seal, there must be the signature or signature of the legal representative himself.9. If the application materials need to be submitted, the applicant (unit) shall indicate the words "this copy is consistent with the original" or the text description on the copy, indicate the date and stamp the official seal of the unit; the individual application shall be signed or signed.10. The application materials should be complete, clear and signed, and stamped with official seal. All application forms shou


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