大兴河西区北京医疗器械三类经营许可证可全包代办专业快捷包下证

（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；10、申请材料应完整、清晰、签字，并逐份加盖公章，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；

 the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) data on product risk analysis; (2) technical requirements of the product; (3) product inspection report; and (4) clinical evaluation data; 10. Application materials shall be complete, clear and signed, And affix the official seal on the official copy by copy, 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