顺义城区北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件人员专业快捷包下证

、一类——不用办理医疗器械许可证第一类医疗器械是风险程度低、实行常规管理可以保证其安全有效的医疗器械，比如手术刀、手术剪、手动病床、医用冰袋、降温贴等，其产品和生产活动由所在地设区的市级食品药品监管部门实行备案管理。经营活动则全部放开，既不用许可也不用备案，只需取得工商部门核发的营业执照即可。

02.

二类——市药监局办理医疗器械经营备案第二类医疗器械是具有中度风险，需要严格控制管理以保证其安全有效的医疗器械，比如我们日常生活中常见的创可贴、避孕套、体温计、血压计、制氧机、雾化器等，其产品和生产活动由省级食品药品监管部门实行许可管理，分别发给《医疗器械注册证》和《医疗器械生产许可证》。经营活动由设区的市级食品药品监管部门实行备案管理;

03.

三类——国家药监局办理医疗器械许可证第三类医疗器械是具有较高风险，需要采取特别措施严格控制管理以保证其安全有效的医疗器械，比如常见的输液器、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等，其产品和生产经营活动分别由、省级食品药品监管部门和设区的市食品药品监管部门实行许可管理，分别发给《医疗器械注册证》、《医疗器械生产许可证》、《医疗器械经营许可证》。

北京公司如何办理增加医疗器械经营范围呢?增加医疗器械经营范围有什么要求呢?徐冰为您详细介绍：

一、公司增加一类医疗器械经营范围

第一类医疗器械是指，通过常规管理足以保证其安全性、有效

edical devices, such as our daily life, band, condoms,thermometer, blood monitor, oxygen generator, atomizer, itsproducts and production activities by the provincial food and drugregulatory department licensing management, respectively issued tothe medical device registration certificate and medical deviceproduction license. Business activities shall be put on record bythe food and drug regulatory departments of the city divided intodistricts; 03. Three —— state food and drug administration licensethe third category of medical devices is a high risk, take specialmeasures to strictly control and management to ensure its safe andeffective medical devices, such as common infusion, syringe,intravenous needle, heart stent, ventilator, CT, NMR, etc., itsproducts and production and business activities by the stateadministration, provincial food and drug regulatory authorities andthe municipal food and drug regulatory departments licensingmanagement, respectively issued to the medical device registrationcertificate, medical device production license, medical devicebusiness license. How does Beijing company