三類(lèi)醫療器械經(jīng)營(yíng)許可證辦理流程及條件

國家對經(jīng)營(yíng)和銷(xiāo)售醫療器械的企業(yè)按照風(fēng)險程度分為三類(lèi)進(jìn)行管理，這也就導致很多人認為醫療器械經(jīng)營(yíng)許可證也分為三類(lèi).

首先，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(lèi)似或者相關(guān)的物品，包括所需要的計算機軟件。而醫療器械經(jīng)營(yíng)許可證是三類(lèi)醫療器械經(jīng)營(yíng)企業(yè)必須具備的證件。

國家對醫療器械按照風(fēng)險程度實(shí)行分類(lèi)管理。

第1類(lèi):

是風(fēng)險程度低，實(shí)行常規管理可以保證其安全、有效的醫療器械。比如手術(shù)刀、手術(shù)剪、紗布繃帶、醫用冰袋、聽(tīng)診器等。

第2類(lèi):

是具有中度風(fēng)險，需要嚴格控制管理以保證其安全、有效的醫療器械。

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