(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备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准备库房 可全程免费指导办理流程,提供质量管理员,也可托管办理,专业速度快速Zui快3天完成备案
t the application of the applicant's application; (3) investigate the actual site and review the product; (4) grant the issuance of the third class 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 product technical requirements; (3) product inspection report; (3) clinical evaluation data; (4) clinical evaluation data; (5) the product specification and label sample; 7. ID card and work certificate of financial personnel; 8, other related materials. Medical equipment filing process: 1, prepare the license copy, official seal, the actual business address room this copy, rental contract 2, need to provide a quality administrator, medical related professional graduate full 3 years 3, online submit medical device filing audit data through offline material 4, medical equipment wholesale warehouse also need to prepare the whole free guidance process, provide quality