丰台洋桥医疗器械三类经营许可证二类备案专业办理快捷包下证

（2）相关部门受理申请人的申请；
（3）到实际场地进行勘察以及对产品进行审核；
（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；
（七）证明产品安全、有效所需的其他资料。
4、工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》的复印件应与原件相同，复印件确认留存，原件退回；5、房产证明、房屋租赁证明（出租方要提供产权证明）应有效；

6、企业负责人、质量管理人的简历、学历证明或职称证明应有效；

7、企业应根据自身实际建立医疗

2) the relevant departments accept the application of theapplicant; (3) investigate the actual site and review the product;(4) grant the issuance of the class iii medical device license.2.legal basis: article 14 of the regulations on supervision andadministration of medical devices for the filing of class i medicaldevices and application for the registration of class ii and iiimedical devices shall submit the following materials: (1) productrisk analysis data; (2) technical re (3) product; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product.4, the copy of the "enterprise name pre-approvalnotice" or "industrial and commercial business license" issued bythe administrative department for industry and commerce shall bethe same as the original, the copy is confirmed and retained, theoriginal is returned; 5, the real estate certificate, house leasecertificate (the lessor to provide the property right certificate)shall be valid; 6. the resume, educational background certificateor professional title certificate of the person in charge of theenterprise and the manager shall be valid; 7. enterprisessh