海淀皂君庙北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷

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；
（五）产品说明书以及标签样稿；办理三类医疗器械经营许可证的办理流程：

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。

首先，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；

materials to the relevant department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices products and the application for the registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; the process for handling the business license of Class III medical devices: There are three types of medical enterprise business licenses, among which the first class medical device license can be directly handled, the operation of second class products needs to apply for the record certificate of second class medical devices, and the operation of third class products needs to apply for the business license of third class medical devices. First of all, the operating enterprise must clarify the conditions for applying for the third type of medical device business license and meet the relevant requirements. (1) It shall have two quality control agencies or quality management personnel suitable for the scale and scope of its business operations. The quality management personnel shall have the relevant professional education background or professional title recognized by the state, and the quality manager shall be on duty and shall not take part-time jobs in other units; (2) having a rela