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，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.

二類——市藥監(jiān)局辦理醫(yī)療器械經(jīng)營(yíng)備案 第二類醫(yī)療器械是具有中度風(fēng)險(xiǎn)，需

oscope, ultrasonic scalpel, color ultrasound imaging e, laser surgery e, high frequency electric knife, microwave treatment instrument, medical nuclear magnetic resonance imaging e, X-ray treatment e, medical high-energy e, artificial cardiopulmonary machine, internal fixation e, artificial heart valve, artificial kidney, respiratory anesthesia e, disposable sterile syringe, disposable infusion set, blood transfusion device, CT e, etc. How to apply for a license? 01. 1, a —— need not to deal with medical device license first type of medical instruments is low risk, routine management can ensure its safe and effective medical instruments, such as scalpel, surgical scissors, manual beds, medical ice packs, c