门头沟周边北京医疗器械二类备案医疗器械三类经营许可证全程托管省心安全Zui快七天下证

三类医疗器械经营许可证办理流程及条件

国家对经营和销售医疗器械的企业按照风险程度分为三类进行管理，这也就导致很多人认为医疗器械经营许可证也分为三类.

首先，什么叫做医疗器械?医疗器械是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品，包括所需要的计算机软件。而医疗器械经营许可证是三类医疗器械经营企业必须具备的证件。

国家对医疗器械按照风险程度实行分类管理。

第1类:

是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。比如手术刀、手术剪、纱布绷带、医用冰袋、听诊器等。

第2类:

是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。比如我们日常生活中常见的体温计、血压计、心电图仪、雾化器等。

nstruments, e, instruments, in vitro diagnosticreagents, calibrators, materials, and other similar or relatedarticles directly or indirectly used in the human body, includingthe required computer software. the medical device business licenseis the certificate that the third class medical device businessenterprise must have. the state implements classified management ofmedical devices according to the risk degree. category 1: it is alow degree of risk, and the implementation of routine managementcan ensure its safe and effective medical devices. such as scalpel,surgical scissors, gauze bandages, medical ice packs, stethoscope,etc. category 2: it is a medical device with moderate risk andneeds strict control and management to ensure its safety andeffectiveness. for example, in