Port communication1、一类——不用办理医疗器械许可证（风险系数低，不需要获得许可证即可经营）类医疗器械是风险程度低、Implementing routine management can ensure the safety and effectiveness of medical devices，Like a scalpel、surgical scissors、Manual hospital bed、medical ice pack、Cooling patches, etc.，Its products and production activities are subject to registration management by the local districted municipal food and drug regulatory authorities.。
All business activities will be liberalized，No permission or registration required，You only need to obtain a business license issued by the industrial and commercial department。2、二类——市药监局办理医疗器械经营备案（风险较低，常规使用可保安全的，如纱布绷带等。
需要获得备案）第二类医疗器械是具有中度风险，Medical devices that require strict control and management to ensure their safety and effectiveness，For example, the common band-aids in our daily life、condom、thermometer、sphygmomanometer、oxygen concentrator、Atomizer, etc.，Its products and production activities are licensed and managed by provincial food and drug regulatory authorities.，Issue "Medical Device Registration Certificate" separately。
Business activities are subject to registration management by the districted municipal food and drug regulatory authorities.;3、三类疗——国家药监局办理医疗器械许可证（风险较高，需要非常专业严谨地使用以确保安全。输液管，intraocular lens。
需要获得许可证明）第三类医疗器械是具有较高风险，Medical devices that require special measures to be strictly controlled and managed to ensure their safety and effectiveness，For example, a common infusion set、syringe、intravenous indwelling needle、heart stent、Ventilator、CT、NMR, etc.，Its products and production and operation activities are separately controlled by the State Administration of、Provincial food and drug regulatory authorities and districted city food and drug regulatory authorities implement licensing management。
Related products：怎样区分一类 , Category II , Class III medical devices
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