（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；10、申请材料应完整、清晰、签字，并逐份万元以上2万元以下罚款。申请人在3年内不得再次申请《医疗器械经营企业许可证》。

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；

tion of Medical Devices and applying for the registration of Class II and Class III medical devices shall submit the following materials: (1) product risk analysis data; (2) product technical requirements; (ii) product inspection report; (3) clinical evaluation data; (4) clinical evaluation data; (5) product specification and label samples; 10, the application materials shall be complete, clear and signed, and impose a fine of between RMB 10,000 yuan and RMB 20,000 yuan. The applicant shall not apply for the Medical Device Business Enterprise License again within 3 years. Procedures for handling the business license of Class III medical devices: 1. Submit application materials for medical device business license to the Food and Drug Administration; 2. Examination of data form of the Food and Drug Administration; 3. Official acceptance of data; 4. Administrative review of relevant departments; 5. On-site evaluation;