通州运河大街北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱周期短Zui快7天下证

（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；1、经营企业提交的《医疗
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。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

basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product technical requirements; (3) product inspection report; (5); (5) clinical evaluation data; product specification and label samples; (6) quality management system documents related to product development and production; 1. Business license of medical and medical devices submitted by the operating enterprise. There are three types of medical enterprise business licenses, among which the first class medical device license