| 醫療器械三類： | 注冊 |
| 醫療器械二類： | 注冊 |
| 注冊公司： | 網絡銷售備案 |
| 單價： | 面議 |
| 發貨期限： | 自買家付款之日起 天內發貨 |
| 所在地： | 直轄市 北京 北京海淀 |
| 有效期至： | 長期有效 |
| 發布時間： | 2023-11-25 06:36 |
| 最后更新： | 2023-11-25 06:36 |
| 瀏覽次數： | 83 |
| 采購咨詢： |
請賣家聯系我
|
三類醫療器械經營許可證辦理流程及條件
國家對經營和銷售醫療器械的企業按照風險程度分為三類進行管理，這也就導致很多人認為醫療器械經營許可證也分為三類.
什么叫做醫療器械?醫療器械是指直接或者間接用于人體的儀器、設備、器具、體外診斷試劑及校準物、材料以及其他類似或者相關的物品，包括所需要的計算機軟件。而醫療器械經營許可證是三類醫療器械經營企業必須具備的證件。
國家對醫療器械按照風險程度實行分類管理。
第1類:
是風險程度低，實行常規管理可以保證其安全、有效的醫療器械。比如手術刀、手術剪、紗布繃帶、醫用冰袋、聽診器等。
第2類:
是具有中度風險，需要嚴格控制管理以保證其安全、有效的醫療器械。比如我們日常生活中常見的體溫計、血壓計、心電圖儀、霧化器等。
and conditions for handling the business license of Class III medical devices The state manages the enterprises that operate and sell medical devices into three categories according to the risk degree, which leads to many people thinking that the business license of medical devices is also divided into three categories. First of all, what is a medical device? Medical devices refer to the instruments, e, instruments, in vitro diagnostic reagents, calibrators, materials, and other similar or related articles directly or indirectly used in the human body, including the required computer software. The medical device business license is the certificate that the third class medical device business enterprise must have. The state implements classified management of medical devices according to the risk degree. Category 1: It is a low degree of risk, and the implementation of routine management can 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 r
