體溫計踩叭、血壓計匪从、制氧機(jī)婆赠、霧化器等泻肯，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，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》拧揽。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;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)險剃盾，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，比如常見的輸液器淤袜、注射器痒谴、靜脈留置針、心臟支架、呼吸機(jī)椰严、CT善王、核磁共振等，其產(chǎn)品和生產(chǎn)經(jīng)營活動分別由铐坠、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酷它，分別發(fā)給《醫(yī)療器械注冊證》荸跃、《醫(yī)療器械生產(chǎn)許可證》遂涛、《醫(yī)療器械經(jīng)營許可證》。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：一柄露、公司增加一類醫(yī)療器械經(jīng)營范圍
第一類醫(yī)療器械是指乏乔，通過常規(guī)管理足以保證其安全性、有效性的醫(yī)療器械窒汤。
一類醫(yī)療許可證無需辦理經(jīng)營許可證蜂镇。如果是生產(chǎn)醫(yī)療器械，則需要到相關(guān)部門備案杉硅。
二给酥、公司增加二類醫(yī)療器械經(jīng)營范圍
ricts; Class III —— State Food and Drug Administration formedical device license Class III medical devices have a high risk,Special measures need to be taken to strictly control and ensuresafe and effective medical devices, Such as common infusion sets,syringes, intravenous indwelling needles, heart stents,ventilators, CT, MRI, etc., Its products and production andbusiness activities shall be licensed by the State GeneralAdministration of China, the provincial food and drug regulatoryauthorities and the food and drug regulatory authorities of thecity divided into districts respectively, The Medical DeviceRegistration Certificate, Medical Device Production License andMedical Device Business License shall be issued respectively. Howdoes Beijing company increase the business scope of medicalequipment? What are the requirements for increasing the businessscope of medical devices? Next, Xu Bing will introduce to you indetail: first, the company increases the business scope of a classof medical devices The first type of medical devices refer to themedical devices that are sufficient to ensure their safety andeffectiveness through routine management. A Class I medical licensedoes not need to apply for a business license. If the manufactureris a medical device, it needs to file with the relevantdepartments. 2. The company has increased the business
