对医疗器械上市流通前进行认证是目前各国政府保证医疗器械产品安全有效的普遍做法,但对医疗器械的认证方式不同国家有不同的方式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。医疗器械作为特殊的商品,它的流通通常是指医疗器械产品从生产企业向医院或其他使 The certification of medical devices before listing and circulation is the common practice of all governments to ensure the safety and effectiveness of medical device products. However, the authentication methods of medical devices are different in different countries. Medical devices refer to the instruments and devices used directly or indirectly in the human body, Instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including the required computer software. Medical equipment as a special commodity, its circulation is usually refers to the medical device products from the manufacturer to the hospital or other