醫療器械經(jīng)營(yíng)許可證》屬于后置審批

可先辦理營(yíng)業(yè)執照

再領(lǐng)取先照后證通知書(shū)

再申請辦理三類(lèi)醫療許可

證書(shū)有效期為5年

醫療器械經(jīng)營(yíng)許可證

01醫療器械經(jīng)營(yíng)許可證分類(lèi)

目前，經(jīng)營(yíng)一類(lèi)的是不需要辦理許可證的，經(jīng)營(yíng)二類(lèi)的備個(gè)案就可以了；經(jīng)營(yíng)三類(lèi)的需要辦理三類(lèi)的醫療器械經(jīng)營(yíng)許可證。

醫療器械的分類(lèi)

1一類(lèi)醫療器械

手術(shù)刀柄和刀片、普通止血鉗、子彈鉗、紗布剝離鉗、海綿鉗、帕巾鉗、皮管鉗、器械鉗、顯微耳針、顯微喉針、顯微耳鉤、顯微喉鉤、顯微槍形麥粒鉗、顯微喉鉗、顯微持針鉗、角膜鑷、眼用鑷、眼用結扎鑷、紗布繃帶、彈力繃帶、石膏繃帶、創(chuàng )口貼、手術(shù)衣、手術(shù)帽、口罩、手術(shù)墊單、手術(shù)洞巾、檢查手套，指套、洗耳球、陰道洗滌器、氣墊、肛門(mén)袋，圈、集尿袋、引流袋等；

2二類(lèi)醫療器械

如體溫計、血壓計、助昕器、制氧機、避孕套、針灸針、心電診斷儀器、無(wú)創(chuàng )監護儀器、光學(xué)內窺鏡、便攜式超聲診斷儀、全自動(dòng)生化分析儀、恒溫培養箱、牙科綜合治療儀、醫用脫脂棉、醫用脫脂紗布等；

3三類(lèi)醫療器械

如植入式心臟起搏器、體外震波碎石機、病人有創(chuàng )監護系統、人工晶體、

medical permission again The certificate is valid for 5 years Medical device business license 01 Medical device business license classification At present, the operation of class I is not a license, the operation of class II case can be; the operation of class III needs a class III of medical device business license. Classification of the medical devices 1 Class I medical device Surgical handle and blade, ordinary hemostatic forceps, bullet clamp, gauze stripping forceps, sponge forceps, pads, forceps, skin forceps, forceps, forceps, microear needle, microlaryngeal needle, microear hook, microear hook, microthroat hook, microlaryngeal forceps, forceps, microneedle forceps, corneal forceps, eye forceps, eye forceps, gauze bandage, elastic bandage, plaster bandage, band-aid, surgical cover, surgical coat, surgical cap, mask, surgical pad, surgical scarf, examinat