通州物资学院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、有效性的医疗器械。

一类医疗许可证无需办理经营许可证。如果是生产医疗器械，则需要到相关部门备案。

二、公司增加二类医疗器械经营范围

二类医疗器械备案要求，根据《医疗器械监督管理条例》凡是从事二类医疗器械经营的单位都需要到所在地设区的市级食品药品监督管理部门备案，二类医疗器械是具有中度风险，需要控制管理以保证其安全、有效的医疗器械。如：医用缝合针、血压计、体温计、心电图机、脑电图机、显微镜、针灸针、生化分析系统、助听器、超声消毒设备、不可吸

ment. 02. Class —— municipal food and drug administration formedical device business for the second type of medical equipment isa moderate risk, need to strictly control management to ensure itssafe and effective medical devices, such as our daily life, band,condoms, thermometer, blood monitor, oxygen generator, atomizer,its products and production activities by the provincial food anddrug regulatory department licensing management, respectivelyissued to the medical device registration certificate and medicaldevice production license. Business activities shall be put onrecord by the food and drug regulatory departments of the citydivided into districts; 03. Three —— state food and drugadministration license the third category of medical devices is ahigh risk, need to take special measures to strictly controlmanagement to ensure its safe and effective medical devices, suchas common infusion, syringe, intravenous indwelling needle, heartstent, ventilator, CT, NMR, etc., its products and production andbusiness activities by the state administration, provincial foodand drug regulatory authorities and regional municipal food anddrug regulatory departments licensing management, respectivelyissued to the medical device registration certificate, medicaldevice production license, medical device business license. Howdoes Beijing company deal with to increase the business scope ofmedical equipment? What are the requirements for increasing thebusiness scope of medical devices? Next, Xu Bing will introduce itto you in detail: 1. The company has increased the business scopeof class I medical devices The first type of medical devices referto the medical devices that are sufficient to ensure their safetyand effectiveness through routine management. A Class I medicallicense does n