《醫(yī)療器械經(jīng)營(yíng)許可證》屬于后置審批

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再申請(qǐng)辦理三類(lèi)醫(yī)療許可

證書(shū)有效期為5年

醫(yī)療器械經(jīng)營(yíng)許可證

01醫(yī)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(yī)療器械經(jīng)營(yíng)許可證。

醫(yī)療器械的分類(lèi)

1一類(lèi)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(mén)袋，圈、集尿袋、引流袋等；

2二類(lèi)醫(yī)療器械

如體溫計(jì)、血壓計(jì)、助昕器、制氧機(jī)、避孕套、針灸針、心電診斷儀器、無(wú)創(chuàng)監(jiān)護(hù)儀器、光學(xué)內(nèi)窺鏡、便攜式超聲診斷儀、全自動(dòng)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(lèi)醫(yī)療器械

如植入式心臟起搏器、體外震波碎石機(jī)、病人有創(chuàng)監(jiān)護(hù)系統(tǒng)、人工晶體、有創(chuàng)內(nèi)窺鏡、超聲手術(shù)刀、彩色超聲成像設(shè)備、激光手術(shù)設(shè)備、高頻電刀、微波治療儀、醫(yī)用核磁共振成像設(shè)備、X線治療設(shè)備、醫(yī)用高能設(shè)備、人工心肺機(jī)、內(nèi)固定器材、人工心臟瓣膜、人工腎、呼吸麻醉設(shè)備、一次性使用無(wú)菌注射器、一次性使用輸液器、輸血器、CT設(shè)備等。

 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, 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, examination gloves, finger cover, ear ball, vaginal washer, air cushion, anal bag, ring, collection, 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