朝阳十里堡北京医疗器械二类备案医疗器械三类经营许可证专业代办全程托管Zui快七天下证

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

business licenses, among which the first class medical device license can be directly handled; For the operation of second class products, it is necessary to apply for the business 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 specify the conditions for applying for the third-class medical device business license and meet them