朝阳管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Zui详细的教程快来看

二、办理医疗器械三类经营许可证的流程是什么？

1. 提交申请

2. 窗口受理

3. 审核材料

4. 老师下户现场检查

5. 审批通过

6. 领取医疗器械三许可证

一、什么是医疗器械？

医疗器械：是指单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品，包括所需要的软件；其用于人体体表及体内的作用不是用药理学、免疫学或者代谢的手段获得，可能有这些手段参与并起一定的辅助作用。

二、医疗器械分几类？

一共三类：

经营第一类医疗器械不需许可和备案，执照上面加上销售医疗器械一类就可以正常销售；

经营第二类医疗器械需要办理备案；

经营第三类医疗器械需要办理经营许可证。

三、办公室和库房需要多大面积？

根据Zui新法规要求：

6840体外诊断试剂含冷链：办公室30平，库房40平，冷链20立方米
剩下所有产品都是：办公室30平，库房40平

vice? Medical device: refers to instruments, equipment,appliances, materials or other articles used individually or incombination, including required software; their use on the surfaceof the body is not obtained by pharmacological, immunology ormetabolic means, but may participate and play a certain auxiliaryrole. 2. How many categories are medical devices divided into?There are three categories: The operation of the first type ofmedical devices does not need permission and record, the licenseplus the sales of medical devices can be sold normally; Theoperation of type II medical devices needs to be put on record; Theoperation of the third type of medical equipment requires theoperation license. How much area does the office and the