西城地安门北京医疗器械三类经营许可证二三类专业快捷包拿证

（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。

（二）具有与经营规模和经营范围相适应的相对独立的经营场所；

（三）具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备

review the product; (4) grant the issuance of a class IIImedical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical Devicesfor the filing of Class I medical devices and application for theregistration of Class II and Class III medical devices, thefollowing data shall be submitted: (1) product risk analysis data;(2) product technical requirements; (3) product inspection report;(4) clinical evaluation data; (5) product description and labelsamples; (6) quality management system documents related to productdevelopment and production; 3. Having technical personnel withtechnical secondary school degree or above; 4. Having qualitymanagement system corresponding to the operation of medical devicesThere are three types of medical enterprise business licenses,among which the first class medical device license can be directlyhandled, the operation of second class products needs to apply forthe record certificate of second class medical devices, and theoperation of third class products needs to apply for the businesslicense of third class medical devices. (2) having a relativelyindependent business site commensurate with the scale and scope ofoperation; (3) It shall have storage conditions suitable for thescale and scope of business, including storage facilities andequipment that meet the requirements of the characteristics ofmedical device products