医疗器械销售需要什么资质

Hong Kong Xintong Peng Yishuo Resources：医疗器械销售要看自己办理的是那一类的医疗器械，二类医疗器械需要进行备案，三类医疗器械需要办理许可证。不过这两个证件相同的特点就是，如果以个人力量或是公司名义自己去办理，会需要花费很长时间，尤其是现在新政策推行，资质审批准备手续是非常复杂的。

有需要的人士建议还是找资质代办公司，Save time and effort。1、一类——不用办理医疗器械许可证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。

1. Category II - The Municipal Food and Drug Administration handles medical device business registration. Category II medical devices have moderate risks.，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" and "Medical Device Production License" respectively。

Business activities are subject to registration management by the districted municipal food and drug regulatory authorities.;3、Category III - The State Food and Drug Administration applies for a medical device license. Category III medical devices carry higher risks.，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，Issue "Medical Device Registration Certificate" separately、"Medical Device Production License"、"Medical Device Business License"。

经营医疗器械产品的企业需要向本地食品药品监督管理局申请《医疗器械经营企业许可证》相关产品：医疗器械销售需要什么资质

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