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(yíng)活動(dòng)分別由、省級食品藥品監管部門(mén)和設區的市食品藥品監管部門(mén)實(shí)行許可管理，分別發(fā)給《醫療器械注冊證》、《醫療器械生產(chǎn)許可證》、《醫療器械經(jīng)營(yíng)許可證》。

北京公司如何辦理增加醫療器械經(jīng)營(yíng)范圍呢?增加醫療器械經(jīng)營(yíng)范圍有什么要求呢?徐冰為您詳細介紹：

一、公司增加一類(lèi)醫療器械經(jīng)營(yíng)范圍

第一類(lèi)醫療器械是指，通過(guò)常規管理足以保證其安全性、有效性的醫療器械。

一類(lèi)醫療許可證無(wú)需辦理經(jīng)營(yíng)許可證。如果是生產(chǎn)醫療器械，則需要到相關(guān)部門(mén)備案。

二、公司增加二類(lèi)醫療器械經(jīng)營(yíng)范圍

二類(lèi)醫療器械備案要求，根據《醫療器械監督管理條例》凡是從事二類(lèi)醫療器械

ements for increasing the business scope of medical devices? Next, Xu Bing will introduce it to you in detail: 1. The company has increased the business scope of class I medical devices The first type of medical devices refers to the medical devices that are sufficient to ensure their safety and effectiveness through routine management. A Class I medical license does not need to apply for a business license. If it is making medical devices, it needs to file with the relevant departments. 2. The company has increased the business scope of class II medical devices Re for the filing of Class II medical de