通州宋庄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

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；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。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

the products; (4) grant the issuance of a class III medicaldevice license.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices for the filing ofClass I medical devices and application for the registration ofClass II and III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product technical requirements; (3) productinspection report; (5); (5) clinical evaluation data; productspecification and label samples; (6) quality management systemdocuments related to product development and production; 1.Business license of medical and medical devices submitted by theoperating enterprise. There are three types of medical enterprisebusiness licenses, among which the first class medical devicelicense