（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
办理三类医疗器械经营许可证的办理流程：
1.向食品药品监督管理局提交医疗器械经营许可证申请材料；
2.食品药品监督管理局数据形式审查；
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
sis: Article 14 of the Regulations on the Supervision andAdministration of Medical Devices The filing of and registration ofClass II and III medical devices shall be submitted: (1) productrisk analysis data; (2) product technical requirements; (3) productinspection report; (4) clinical evaluation data; (5) productinstructions and label samples; what materials are required for theregistration of Class III medical devices; 1. the operation ofmedical devices submitted by the operating enterprise Proceduresfor handling the business license of Class III medical devices: 1.Submit application materials for medical device business license tothe Food and Drug Administration; 2. Form review of data of theFood and Drug Administration; 3. Official acceptance of data; 4.Administrative review of relevant departments; 5. On-siteevaluation; 6. administration of relevant departments
