丰台和义北京医疗器械二类备案医疗器械三类经营许可证放心一站式代办周期短下证快

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，但是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

 other articles used individually or in combination,including required software; their use on the surface of the bodyis not obtained by pharmacological, immunology or metabolic means,but may participate and play a certain auxiliary role. 2. how manycategories are medical devices divided into? there are threecategories: the operation of the first type of medical devices doesnot need permission and record, the license plus the sales ofmedical devices can be sold normally; the operation of type iimedical devices needs to be put on record; the operation of thethird type of medical e requires the operation license. howmuch area does the office and the warehouse need? according to thelatest regulatory re: 6840 in vitro