《醫(yī)療器械經(jīng)營許可證》屬于后置審批

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醫(yī)療器械經(jīng)營許可證

01醫(yī)療器械經(jīng)營許可證分類

目前，經(jīng)營一類的是不需要辦理許可證的，經(jīng)營二類的備個案就可以了；經(jīng)營三類的需要辦理三類的醫(yī)療器械經(jīng)營許可證。

醫(yī)療器械的分類

1一類醫(yī)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(jié)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、肛門袋，圈、集尿袋、引流袋等；

2二類醫(yī)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、無創(chuàng)監(jiān)護儀器、光學(xué)內(nèi)窺鏡、便攜式超聲診斷儀、全自動生化分析儀、恒溫培養(yǎng)箱、牙科綜合治療儀、醫(yī)用脫脂棉、醫(yī)用脫脂紗布等；

3三類醫(yī)療器械

ollection, urine bag, drainage bag, etc.; 2 Class II medical devices Such as thermometer, blood pressure monitor, aid, oxygen generator, condoms, acupuncture needle, ECG diagnostic instrument, non-invasive monitoring instrument, optical endoscope, portable ultrasonic diagnostic instrument, automatic biochemical analyzer, constant temperature incubator, dental comprehensive treatment instrument, medical skim cotton, medical degreasing gauze, etc.; 3 Class III medical devices