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医疗器械分为一二三类，每个类里面的产品是不一样的，主要看做的那类产品，然后根据您的产品来哪一类的资质，有的客户就是直接把二三类都批下来，免得后期在经营，但是您在批资质的时候需要一个产品的注册证，这个是需要提供的，所以最好您有该产品的注册证在办理。
办理医疗器械需要的材料：公司执照正副本；公司公章，章程；法人身份证复印件及学历等一些信息；公司其他人员的相关证书；办公软件；址的租赁合同；其他的一些材料
办理二类需要提供的材料
办理二类的话看您是不是有试剂
上述所需资料还有一下资料：库房的租赁合同；质量管理人的证书、身份证复印件及简历；办公面积的租赁合同；产品的注册证；其他药监局需要提供的必要资料