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
西城积水潭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
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;
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对申请材料的要求:

1、经营企业提交的《医疗器械经营企业许可证申请表》应有法定代表人签字或加盖企业公章;

te 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 application for the registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (1) product technical requirements; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (4) clinical evaluation data; (5) product instructions and label samples; the enterprise also needs to prepare the warehouse to guide the whole process free of charge, provide quality administrators, and complete the record in 3 days Requirements for the application materials: 1. The Application Form for Medical Device Business Enterprise License submitted by the operating enterprise shall be signed by the legal representative or affixed with the official seal of the enterprise;


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