(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
edical device license.2. Legal basis: Article 14 of theRegulations on the Supervision and Administration of MedicalDevices for Class 1, the following materials shall be submitted:(1) product risk analysis data; (2) the product technicalrequirements; (3) product inspection report; (3) clinicalevaluation data; (4) clinical evaluation data; (5) the productspecification and label sample; 7. ID card and work certificate offinancial personnel; 8, other related materials. Medical devicesclass II filing process: 1, prepare the license copy, officialseal, a copy of the actual business address room, rental contract2, need