《醫療器械經營許可證》屬于后置審批

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再申請辦理三類醫療許可

證書有效期為5年

醫療器械經營許可證

01醫療器械經營許可證分類

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

醫療器械的分類

1一類醫療器械

手術刀柄和刀片、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、創口貼、手術衣、手術帽、口罩、手術墊單、手術洞巾、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、無創監護儀器、光學內窺鏡、便攜式超聲診斷儀、全自動生化分析儀、恒溫培養箱、牙科綜合治療儀、醫用脫脂棉、醫用脫脂紗布等；

3三類醫療器械

如植入式心臟起搏器、體外震波碎石機、病人有創監護系統、人工晶體、有創內窺鏡、超聲手術刀、彩色超聲成像設備、激光手術設備、高頻電刀、微波治療儀、醫用核磁共振成像設備、X線治療設備、醫用高能設備、人工心肺機、內固定器材、人工心臟瓣膜、人工腎、呼吸麻醉設備、一次性使用無菌注射器、一次性使用輸液器、輸血器、CT設備等。

 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