注射器、靜脈留置針、心臟支架、呼吸機(jī)、CT、核磁共振等，其產(chǎn)品和生產(chǎn)經(jīng)營(yíng)活動(dòng)分別由、省級(jí)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(shí)行許可管理，分別發(fā)給《醫(yī)療器械注冊(cè)證》、《醫(yī)療器械生產(chǎn)許可證》、《醫(yī)療器械經(jīng)營(yíng)許可證》。

北京公司如何辦理增加醫(yī)療器械經(jīng)營(yíng)范圍呢?增加醫(yī)療器械經(jīng)營(yíng)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(yíng)范圍

第一類醫(yī)療器械是指，通過(guò)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(wú)需辦理經(jīng)營(yíng)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。

二、公司增加二類醫(yī)療器械經(jīng)營(yíng)范圍

二類醫(yī)療器械備案要求，根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》凡是從事二類醫(yī)療器械經(jīng)營(yíng)的單位都需要到所在地設(shè)區(qū)的市級(jí)食品藥品監(jiān)督管理部門備案，二類醫(yī)療器

dical devices, it needs to be filed with the relevant department. 2. The company has increased the business scope of class II medical devices The filing re of Class II medical devices, according to the "Regulations on supervision and Administration of Medical Devices", all units engaged in the business of Class II medical devices need to put on record with the municipal food and drug supervision and administration department, Class II medical devices