海淀北航北京医疗器械二类备案医疗器械三类经营许可证专业代办全程托管Zui快七天下证

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.

management can ensure its safe and effective medical instruments, 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.