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，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、注射器、靜脈留置針、心臟支架、呼吸機、CT、核磁共振等，其產(chǎn)品和生產(chǎn)經(jīng)營活動分別由、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，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》。

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、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)管理足以保證其安全性、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。如果是生產(chǎn)醫(yī)療器械，則需要到相關(guān)部門備案。

needle, heart stent, ventilator, CT, NMR, etc., its products and production and business activities by the state administration, provincial food and drug regulatory authorities and regional municipal food and drug regulatory departments licensing management, respectively issued to the medical device registration certificate, medical device production license, medical device business license. How does Beijing company increase the business