西城鼓楼北京医疗器械三类经营许可证二三类专业快捷包拿证

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；
（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；
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度

医疗企业经营许可证一共有三类，其中办理一类医疗器械许可证可以直接办理，经营二类产品是需要办理二类医疗器械经营备案凭证，经营三类产品则需要办理三类医疗器械经营许可证。

经营企业必须明确申请三类医疗器械经营许可证的条件并满足相关要求。

（一）具有与经营规模和经营范围相适应的质量管理机构或者质

edical device business license is handled as follows: (1) theapplicant submits the application materials to the relevantdepartments; (2) the relevant departments accept the application ofthe applicant; (3) investigate the actual site and reviews 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 application for the registration ofClass II and Class III medical devices, the following data shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) clinicalevaluation data; (5) product description and label samples; (6)quality management system documents related to product developmentand production; 3. Having technical personnel with technicalsecondary school degree or above; 4. Having quality managementsystem corresponding to the operation of medical devices There arethree types of medical enterprise business licenses, among whichthe first class medical device license can be directly handled, theoperation of second class products needs to apply for the recordcertificate of second class medical devices, and the operation ofthird class products needs to apply for the business license ofthird class medical devices. First of all, the operating enterprisemust clarify the conditions for applying for the third type ofmedical device business license and meet the relevant requirements.(1) It shall have a quality management agency or quality suitablefor