医疗器械二三类资质注册咨询，快速办理，便宜咨询

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。

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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;

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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国家总局、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》。

ment, such as scalpel, surgical scissors, manual beds, medicalice packs, cooling paste, etc., its products and productionactivities by the local district municipal food and drug regulatorydepartments for the record management. business activities are allopen, neither need to put on record, only need to obtain thebusiness license issued by the industry and commerce department.02. class —— municipal food and drug administration for medicaldevice business for the second type of medical e is amoderate 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, take special measures to strictly control and managementto ensure its safe and effective medical devices, such as