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(xiǎn)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(jì)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(xiǎn)程度實(shí)行分類管理。

第1類:

是風(fēng)險(xiǎn)程度低，實(shí)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(xiǎn)，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(jì)、血壓計(jì)、心電圖儀、霧化器等。

第3類:

是具有較高風(fēng)險(xiǎn)，需要采取特別措施嚴(yán)格控制管理以保證其安全、有效的醫(yī)療器械。比如常見的銷售xinguan實(shí)際檢測盒、隱形眼鏡、注射器、靜脈留置針、心臟支架、呼吸機(jī)、CT、核磁共振等。

醫(yī)療器械經(jīng)營許可證現(xiàn)為后置審批，有效期為5年。有效期屆滿需要延續(xù)的，依照有關(guān)行政許可的法律規(guī)定辦理延續(xù)手續(xù)。

一、三類醫(yī)療器知械許可證注冊所需材料

1、企業(yè)名稱與經(jīng)營范圍，注冊資本及股東出資比例，股東等身份證明;

2、醫(yī)療器械產(chǎn)品注冊證書、供應(yīng)商營業(yè)執(zhí)照、許可證及授權(quán)書;

es 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 ha