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。
第3类:
是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。比如常见的销售xinguan实际检测盒、隐形眼镜、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等。
医疗器械经营许可证现为后置审批，有效期为5年。有效期届满需要延续的，依照有关行政许可的法律规定办理延续手续。
directly or indirectly used in the human body, including therequired computer software. The medical device business license isthe 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. Category 3: It is a medical device with highrisk and needs to take special measures to strictly control andmanage it to ensure its safety and effectiveness. For example, thecommon sales of COV actual detection box, contact lenses, syringe,intravenous indwelling needle, heart stents, ventilators, CT,nuclear magnetic resonance, etc. The medical device businesslicense is now post-approval and valid for 5 years. If the term ofvalidity needs to
