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丰台左安门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

发布时间:2023-12-16        浏览次数:4        返回列表
前言:医疗器械三类,注册公司,医疗器械二类,网络销售备案,辐射许可证
丰台左安门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

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;
(六)与产品研制、生产有关的质量管理体系文件;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

pplicant's application; (3) 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 Supervision and Administration of Medical Devices for the filing of Class I medical devices and for the registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (3) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; 7. Enterprises shall establish quality management files or forms of medical devices according to their actual conditions.8. The self-guarantee statement of the authenticity of the application materials shall be signed and added by the legal representative


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