海淀定慧寺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

三类医疗器械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下：
（1）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；4、工商行政管理部门出具的《企业名称预先核准通知书》
6.有关部门的行政决定；
7.制证、发证。
办理三类医疗器械经营许可证的条件如下：
1、具有与经营范围相匹配的经营场所和仓库，并对其具体面积有具体要求；
2、具有国家认可的、与经营产品相关专门的在岗人员；
3、具有与经营产品相关的拥有中专以上学历的技术人员；
4、拥有与经营的医疗器械相适应的质量管理制

the product; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and for the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (4); 4. Notice of Pre-approval of Enterprise Name issued by the administrative department of industry and commerce 6. Administrative decision of relevant departments; 7. Certificate making and certification. The conditions for the business license of Class III medical devices are as follows: 1. business premises and warehouses matching with business scope with specific requirements for their specific area; 2. Specialized personnel related to business products; 3. technical personnel with technical secondary school or above related to business products; 4. quality management system for to medical devices