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；
（六）与产品研制、生产有关的质量管理体系文件；
对申请材料的要求：
1、经营企业提交的《医疗器械经营企业许可证申请表》应有法定代表人签字加盖企业公章；2、《医疗器械经营企业许可证申请表》所填写项目应填写齐全、准确；3、
f the Regulations on the Supervision and Administration ofMedical Devices, Class 1, shall submit the following materials: (1)product risk analysis data; (2) product technical requirements; (3)product inspection report; (4) product inspection report; (4)clinical evaluation data; product specification and label samples;(6) quality management system documents related to the productdevelopment and production; requirements for the applicationmaterials: 1. The Application Form for Medical Device EnterpriseLicense submitted by the operating enterprise shall be signed bythe legal representative with the official seal of the enterprise;2. The items filled in the Application Form for Medical DeviceEnterprise License shall be complete and accurate; 3
