（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；医疗器械二类备案流程：1、准备执照副本，
3.数据正式受理；
4.有关部门的行政审查；
5.现场评价；
6.有关部门的行政决定；
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
al device license.2. Legal basis: Article 14 of the Regulationson Supervision and Administration of Medical Devices for filing ofClass I medical devices and application for registration of ClassII and Class III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (2) product technical requirements; (3) productinspection report; (4) clinical evaluation data; (5) productinstructions; and label samples; filing process of medical devices:1. Preparation of license copies; 3. Official acceptance of data;4. Administrative review of relevant departments; 5. On-siteevaluation; 6. Administrative decisions of relevant departments; 7.Certificate preparation and issuance. The conditions for applyingfor the business license of Class III medical devices are asfollows: 1. Having business premises and warehouses matching thebusiness scope, and having specific requirements for their specificarea; 2. Having nationally recognized professional employeesrelated to the business products
