医疗器械产品分为一类、二类、三类;

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。

二类:市药监局办理医疗器械经营备

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

Where there are errors in the application materials that can be corrected on the spot, The applicant shall be allowed to make corrections on the spot; if the application materials are incomplete or do not conform to the statutory form, Should inform the applicant on the spot or within five days of all the contents to be corrected, Failure to inform you after the time limit, It shall be accepted from the date of receipt of the application materials; The matters to apply for fall within the scope of the functions and powers of the administrative organ, The application materials are complete and in line with the legal form, Or where the applicant submits all the supplementary and corrected application materials as required by the respective administrative organ, The application for administrative license shall be accepted.