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(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,。

怎樣辦理許可證？

01.

1,、一類——不用辦理醫(yī)療器械許可證 第一類醫(yī)療器械是風(fēng)險(xiǎn)程度低,、實(shí)行常規(guī)管理可以保證其安全有效的醫(yī)療器械，比如手術(shù)刀,、手術(shù)剪、手動(dòng)病床,、醫(yī)用冰袋,、降溫貼等，其產(chǎn)品和生產(chǎn)活動(dòng)由所在地設(shè)區(qū)的市級(jí)食品藥品監(jiān)管部門實(shí)行備案管理,。經(jīng)營(yíng)活動(dòng)則全部放開(kāi),，既不用許可也不用備案，只需取得工商部門核發(fā)的營(yíng)業(yè)執(zhí)照即可,。

02.

t hook, microthroat forceps, microthroat forceps, microneedle forceps, corneal forceps, eye forceps, eye forceps ligation forceps, gauze bandage, elastic bandage, plaster bandage, band-aid, surgical cover, surgical cap, 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 Class III medical devices Such as implantable cardiac pacemaker, external shock wave lithotripsy machine, patient i