像設(shè)備恒建、X線治療設(shè)備榨凭、醫(yī)用高能設(shè)備捞奕、人工心肺機(jī)容燕、內(nèi)固定器材琅拌、人工心臟瓣膜缨伊、人工腎、呼吸麻醉設(shè)備进宝、一次性使用無菌注射器刻坊、一次性使用輸液器枷恕、輸血器、CT設(shè)備等易祖。

怎樣辦理許可證遵艰？

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)險程度低悍写、實行常規(guī)管理可以保證其安全有效的醫(yī)療器械电摔，比如手術(shù)刀、手術(shù)剪暴艘、手動病床稀崔、醫(yī)用冰袋、降溫貼等柬沾，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泉剔。經(jīng)營活動則全部放開，既不用許可也不用備案住秉，只需取得工商部門核發(fā)的營業(yè)執(zhí)照即可假却。

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(yán)格控制管理以保證其安全有效的醫(yī)療器械睹傻，比如我們?nèi)粘Ｉ钪谐Ｒ姷膭?chuàng)可貼像捶、避孕套、體溫計桩砰、血壓計拓春、制氧機(jī)、霧化器等亚隅，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硼莽，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)險煮纵，需要采取特別措施嚴(yán)格控制管理以保證其安全有效的醫(yī)療器械懂鸵，比如常見的輸液器、注射器行疏、靜脈留置針匆光、心臟支架、呼吸機(jī)酿联、CT终息、核磁共振等，其產(chǎn)品和生產(chǎn)經(jīng)營活動分別由贞让、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艺滑，分別發(fā)給《醫(yī)療器械注冊證》、《醫(yī)療器械生產(chǎn)許可證》、《醫(yī)療器械經(jīng)營許可證》跳犹。

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(xì)介紹：

一塌卜、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，通過常規(guī)管理足

ricts; 03. Three —— state food and drug administration licensethe third category of medical devices is a high risk, need to takespecial measures to strictly control management to ensure its safeand effective medical devices, such as common infusion, syringe,intravenous needle, heart stent, ventilator, CT, NMR, etc., itsproducts and production and business activities by the stateadministration, provincial food and drug regulatory authorities andregional municipal food and drug regulatory departments licensingmanagement, respectively issued to the medical device registrationcertificate, medical device production license, medical devicebusiness license. How does Beijing company deal with to increasethe business scope of medical equipment? What are the requirementsfor increasing the business scope of medical devices? Next, Xu Bingwill introduce it to you in detail: 1. The company has increa