怎樣辦理許可證距芬？
01.
1子特、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)險程度低腿椎、實行常規(guī)管理可以保證其安全有效的醫(yī)療器械优烧，比如手術(shù)刀、手術(shù)剪庸娱、手動病床着绊、醫(yī)用冰袋、降溫貼等涌韩，其產(chǎn)品和生產(chǎn)活動由所在地設(shè)區(qū)的市級食品藥品監(jiān)管部門實行備案管理畔柔。經(jīng)營活動則全部放開，既不用許可也不用備案模朋，只需取得工商部門核發(fā)的營業(yè)執(zhí)照即可布橄。
02.
二類——市藥監(jiān)局辦理醫(yī)療器械經(jīng)營備案第二類醫(yī)療器械是具有中度風(fēng)險，需要嚴格控制管理以保證其安全有效的醫(yī)療器械谆府，比如我們?nèi)粘Ｉ钪谐Ｒ姷膭?chuàng)可貼荠涂、避孕套、體溫計灯趁、血壓計裙靶、制氧機、霧化器等稼炉，其產(chǎn)品和生產(chǎn)活動由省級食品藥品監(jiān)管部門實行許可管理犹喜，分別發(fā)給《醫(yī)療器械注冊證》和《醫(yī)療器械生產(chǎn)許可證》。經(jīng)營活動由設(shè)區(qū)的市級食品藥品監(jiān)管部門實行備案管理;
03.
三類——國家藥監(jiān)局辦理醫(yī)療器械許可證第三類醫(yī)療器械是具有較高風(fēng)險草嫉，需要采取特別措施嚴格控制管理以保證其安全有效的醫(yī)療器械阎敬，比如常見的輸液器、注射器症慰、靜脈留置針魄帽、心臟支架、呼吸機凯傲、CT犬辰、核磁共振等，其產(chǎn)品和生產(chǎn)經(jīng)營活動分別由冰单、省級食品藥品監(jiān)管部門和設(shè)區(qū)的市食品藥品監(jiān)管部門實行許可管理幌缝，分別發(fā)給《醫(yī)療器械注冊證》、《醫(yī)療器械生產(chǎn)許可證》诫欠、《醫(yī)療器械經(jīng)營許可證》狮腿。
北京公司如何辦理增加醫(yī)療器械經(jīng)營范圍呢?增加醫(yī)療器械經(jīng)營范圍有什么要求呢?徐冰為您詳細介紹：
一、公司增加一類醫(yī)療器械經(jīng)營范圍
第一類醫(yī)療器械是指呕诉，通過常規(guī)管理足以保證其安全性缘厢、有效性的醫(yī)療器械。
一類醫(yī)療許可證無需辦理經(jīng)營許可證甩挫。如果是生產(chǎn)醫(yī)療器械贴硫，則需要到相關(guān)部門備案。
erce Department. 02. Class —— municipal food and drugadministration for medical device business for the record type ofmedical equipment is a moderate risk, need to strictly controlmanagement to ensure its safe and effective medical devices, suchas our daily life, band, condoms, thermometer, blood monitor,oxygen generator, atomizer, its products and production activitiesby the provincial food and drug regulatory department licensingmanagement, respectively issued to the medical device registrationcertificate and medical device production license. Businessactivities shall be put on record by the food and drug regulatorydepartments of the city divided into districts; 03. Three —— statefood and drug administration license the third category of medicaldevices is a high risk, take special measures to strictly controland management to ensure its safe and effective medical devices,such as common infusion, syringe, intravenous needle, heart stent,ventilator, CT, NMR, etc., its products and production and businessactivities by the state administration, provincial food and drugregulatory au
