丰台木樨园北京医疗器械二类备案医疗器械三类经营许可证用心服务全程保密周期短下证快

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、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》。

medical device license the third type of medical e is ahigh risk, take special measures to strictly control and managementto ensure the safe and effective of medical devices, such as commoninfusion, syringe, intravenous needle, heart stent, ventilator, ct,mri, etc., its products and production and business activities bythe state administration, provincial food and drug regulatoryauthorities and the municipal food and drug regulatory departmentslicensing management, respectively issued medical deviceregistration certificate, medical device production license andmedical device business license.