三類(lèi)——國家藥監局辦理醫療器械許可證 第三類(lèi)醫療器械是具有較高風(fēng)險，需要采取特別措施嚴格控制管理以保證其安全有效的醫療器械，比如常見(jiàn)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(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?接下來(lái)，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。

 of medical devices is a high risk, take special measures to strictly control and management to ensure its safe and effective medical devices, such as common infusion, syringe, intravenous 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 the 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 deal with to increase the business scope of medical e? What are the re for increasing the business scope of medical devices? Next, Xu Bing will introduce it to you in detail: 1. The company has inc