（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1、经营企业提交的《医疗器械经营
7.制证、发证。
办理三类医疗器械经营许可证的条件如下：
1、具有与经营范围相匹配的经营场所和仓库，并对其具体面积有具体要求；
2、具有国家认可的、与经营产品相关专门的在岗人员；
3、具有与经营产品相关的拥有中专以上学历的技术人员；
4、拥有与经营的医疗器械相适应的质量管理制度
e Supervision and Administration of Medical Devices for thefiling of Class I medical devices and application for theregistration of Class II and III medical devices, the followingdata shall be submitted: (1) product risk analysis data; (2)product technical requirements; (3) product; (3) product inspectionreport; (4) clinical evaluation data; (5) product specification andlabel sample; what materials are required for the registration ofClass II and III medical devices 1. Issuance of Medical DeviceBusiness submitted by the operating enterprise. The conditions forhandling the business license of Class III medical devices are asfollows: 1. business premises and warehouses matching with businessscope with specific requirements for their specific area; 2.Specialized duty personnel related to business products; 3.technical personnel with technical secondary school or aboverelated to business products; 4. quality management system suitableto operating medical devices
