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。比如我們日常生活中常見(jiàn)的體溫計、血壓計、心電圖儀、霧化器等。

第3類(lèi):

是具有較高風(fēng)險，需要采取特別措施嚴格控制管理以保證其安全、有效的醫療器械。比如常見(jiàn)的銷(xiāo)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、CT、核磁共振等。

醫療器械經(jīng)營(yíng)許可證現為后置審批，有效期為5年。有效期屆滿(mǎn)需要延續的，依照有關(guān)行政許可的法律規定辦理延續手續。

一、三類(lèi)醫療器知械許可證注冊所需材料

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

2、醫療器械產(chǎn)品注冊證書(shū)、供應商營(yíng)業(yè)執照、許可證及授權書(shū);

3、質(zhì)量管理文件等;

4、2個(gè)或以上醫學(xué)專(zhuān)業(yè)或相關(guān)專(zhuān)業(yè)人員證書(shū)、身份證明與簡(jiǎn)歷;

 and needs strict control and management to ensure its safety and effectiveness. For example, in our daily life, the common thermometer, sphygmomanometer, electrocardiogram instrument, atomizer and so on. Category 3: It is a medical device with high risk and needs to take special measures to strictly control and manage it to ensure its safety and effectiveness. For example, the common sales of COV actual detection box, contact lenses, syringe, intravenous indwelling needle, heart stents, ventilators, CT, nuclear magnetic resonance, etc. The medical device business license is now post-approval and valid for 5 years. If the term of validity needs to be extended upon the expiration of the term, the extension procedures shall be handled in accordance with the relevant legal provisions of the administrative license. 1. Materials required for the registration of third III medical e license 1. Enterprise name and business scope, registered capital a