海淀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

如植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波治疗仪、医用核磁共振成像设备、X线治疗设备、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT设备等。

怎样办理许可证？

01.

1、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、

psy machine, patient invasive monitoring system, artificial lens, invasive endoscope, ultrasonic scalpel, color ultrasound imaging equipment, laser surgery equipment, high frequency electric knife, microwave treatment instrument, medical nuclear magnetic resonance imaging equipment, X-ray treatment equipment, medical high-energy equipment, heart artificial machine, internal fixation equipment, artificial heart valve, artificial kidney, respiratory anesthesia equipment, disposable sterile syringe, disposable infusion set, blood transfusion device, CT equipment, etc. How to apply for a license? 01. 1, a —— need not to deal with medical device license first type of medical equipment is low risk, routine management can ensure its safe and effective medical equipment, such as scalpel, surgical scissors, manual beds, medical ice packs, cooling paste, etc., its products and production activities by the local district municipal food and drug regulatory departments for the record management. Business activities are all open, neither need to put on record, only need to obtain the business license issued by the industry and Commerce Department. 02. Class —— municipal food and drug administration for medical device business for the second type of medical equipment is a moderate risk, need to strictly control management to ensure its safe 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 and drug regulatory department licensing management, respectively issued to the medical devi