朝阳潘家园北京医疗器械三类经营许可证二三类专业快捷包拿证

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量管理人员两个。质量管理人员应当具有国家认可的相关专业学历或者职称，质量管理人应在职在岗，不得在其他单位兼职；

（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

al basis: Article 14 of the Regulations on the Supervision andAdministration of Medical Devices As for the registration of ClassII and III medical devices, the following materials shall besubmitted: (1) Product risk analysis data; (2) Technicalrequirements for the products; (3) Product inspection report; (4)Clinical evaluation data; (5) Product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. There are three typesof medical enterprise business licenses, among which the firstclass medical device license can be directly handled, the operationof second class products needs to apply for the record certificateof second class medical devices, and the operation of third classproducts needs to apply for the business license of third classmedical devices. First of all, the operating enterprise mustclarify the conditions for applying for the third type of medicaldevice business license and meet the relevant requirements. (1) Itshall have two quality control agencies or quality managementpersonnel suitable for the scale and scope of its businessoperations. The quality management personnel shall have therelevant professional education background or professional titlerecognized by the state, and the quality manager shall be on dutyand shall not take part-time jobs in other units; (2) having arelatively independent business site commensurate with the scaleand scope of operation