三類醫(yī)療器械經(jīng)營許可證辦理流程及條件

國家對經(jīng)營和銷售醫(yī)療器械的企業(yè)按照風(fēng)險程度分為三類進(jìn)行管理，這也就導(dǎo)致很多人認(rèn)為醫(yī)療器械經(jīng)營許可證也分為三類.

什么叫做醫(yī)療器械?醫(yī)療器械是指直接或者間接用于人體的儀器、設(shè)備、器具、體外診斷試劑及校準(zhǔn)物、材料以及其他類似或者相關(guān)的物品，包括所需要的計算機(jī)軟件。而醫(yī)療器械經(jīng)營許可證是三類醫(yī)療器械經(jīng)營企業(yè)必須具備的證件。

國家對醫(yī)療器械按照風(fēng)險程度實行分類管理。

第1類:

是風(fēng)險程度低，實行常規(guī)管理可以保證其安全、有效的醫(yī)療器械。比如手術(shù)刀、手術(shù)剪、紗布繃帶、醫(yī)用冰袋、聽診器等。

第2類:

是具有中度風(fēng)險，需要嚴(yán)格控制管理以保證其安全、有效的醫(yī)療器械。比如我們?nèi)粘Ｉ钪谐Ｒ姷捏w溫計、血壓計、心電圖儀、霧化器等。

ts 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 risk and needs strict control and management to ensure its safety and effectiveness. For example, in our daily life, the common thermometer,