门头沟潭柘寺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;
二、三类医疗器械许可证注册需要什么材料
7、财务人员身份证和上岗证;
8、其它相关材料。
医疗器械二类备案流程: 1、准备执照副本,公章,实际经营地址房本复印件,租房合同 2、需要提供一名质量管理员,医学医护相关专业毕业满3年的 3、网上提交医疗器械二类
t the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for Class 1, the following materials shall be submitted: (1) product risk analysis data; (2) the technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; what materials are required for the registration of Class II medical devices; 7, identity card and work certificate of financial personnel; 8, other related materials. Filing process of medical devices: 1. Prepare a copy of license, official seal, copy of actual business address, and rental contract; 2. Provide a quality administrator who has graduated from medical care related ma