朝阳工体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

（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；

办理，在接受资料后的30天内进行审核，如果符合相关规定，就可以颁发三类医疗器械经营许可证。

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；

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 two quality control agencies or qualitymanagement personnel suitable for the scale and scope of itsbusiness operations. The quality management personnel shall havethe relevant professional education background or professionaltitle recognized by the state, and the quality manager shall be onthe job and shall not take part-time jobs in other units; (2)having a relatively independent business site commensurate with thescale and scope of operation; (3) It shall have storage conditionscommensurate with the scale and scope of business, includingstorage facilities and equipment that meet the requirements of thecharacteristics of medical devices;