海淀西二旗北京医疗器械三类经营许可证提供人员库房专业快捷包下证

（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