丰台右安门北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱周期短Zui快7天下证

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、

 need not to deal with medical device license first type ofmedical equipment is low risk, routine management can ensure itssafe and effective medical equipment, such as scalpel, surgicalscissors, manual beds, medical ice packs, cooling paste, etc., itsproducts and production activities by the local districts of themunicipal food and drug regulatory departments for the recordmanagement. Business activities are all open, neither need to puton record, only need to obtain the business license issued by theindustry and Commerce Department. 02. Class —— municipal food anddrug administration for medical device business for the second typeof medical equipment is a moderate risk, need to strictly controlmanagement to ensure its safe and effective medical devices, suchas our daily life, band, condoms,