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。
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 our daily life, the commonthermometer, sphygmomanometer, electrocardiogram instrument,atomizer and so on.
