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丰台总部基地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:3        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
丰台总部基地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

ication of the applicant'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 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 signatu


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