北京平谷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经验丰富靠谱周期短快7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。

the business license of class iii medical devices the statemanages the enterprises that operate and sell medical devices intothree categories according to the risk degree, which leads to manypeople thinking that the business license of medical devices isalso divided into three categories. first of all, what is a medicaldevice? medical devices refer to the instruments, e,instruments, in vitro diagnostic reagents, calibrators, materials,and other similar or related articles directly or indirectly usedin the human body, including the required computer software. themedical device business license is the certificate that the thirdclass medical device business enterprise must have. the stateimplements classified management of medical devices according tothe risk degree. category 1: it is a low degree of risk, andthe