丰台新发地医疗器械三类经营许可证二类备案专业办理快捷包下证

）申请人提交申请资料到相关部门；
（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。
医疗器械二类备案流程：1、准备执照副本，公章，实际经营地址房本复印件，租房合同2、需要提供一名质量管理员，医学医护相关专业毕业满3年的3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准备库房 可全程免费指导办理流程，提供质量管理员，也可托管办理，专业速度快速*快3天完成备

e applicant; (3) investigate the actual site and review theproduct; (4) grant the issuance of the third III medical devicelicense.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices For the filing ofClass I medical devices and the application for the registration ofClass II and III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) clinicalevaluation data; (5) product instructions and label samples; (6)quality management system documents related to product developmentand production; (7) other materials required to prove the safetyand effectiveness of the product. Medical equipment class filingprocess: 1, to prepare the license copy, official seal, the actualbusiness address room this copy, rental contract 2, need to providea quality administrator, medical related professional graduate full3 years of 3, online medical device class filing audit data throughoffline material 4, medical equipment wholesale warehouse also needto guide the free process, provide quality administrator, can alsobe managed, professional speed fast fastest 3