海淀西山北京醫(yī)療器械三類經(jīng)營(yíng)許可證，醫(yī)療器械二類備案提供進(jìn)銷存軟件人員專業(yè)快捷包下證

體溫計(jì)、血壓計(jì)、制氧機(jī)、霧化器等，其產(chǎn)品和生產(chǎn)活動(dòng)由省級(jí)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》和《醫(yī)療器械生產(chǎn)許可證》。經(jīng)營(yíng)活動(dòng)由設(shè)區(qū)的市級(jí)食品藥品監(jiān)管部門實(shí)行備案管理;三類——國(guó)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(xiǎn)，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(jiàn)的輸液器、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?接下來(lái)，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

ricts; Class III —— State Food and Drug Administration for medical device license Class III medical devices have a high risk, Special measures need to be taken to strictly control and ensure safe and effective medical devices, Such as common infusion sets, syringes, intravenous indwelling needles, heart stents, ventilators, CT, MRI, etc., Its products and production and business activities shall be licensed by the State General Administration of China, the provincial food and drug regulatory authorities and the food and drug regulatory authorities of the city divided into districts respectively, The Medical Device Registration Certificate, Medical Device Production License and Medical Device Business License shall be issued respectively. How does Beijing company increase the business scope of medical equipment? What are the requirements for increasing the business scope of medical devices? Next, Xu Bing will introduce to you in detail: first, the company increases the business scope of a class of medical devices The first type of medical devices refer 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 the manufacturer is a medical device, it needs to file with the relevant departments. 2. The company has increased the business