提交第二类医疗器械经营备案凭证申请和医疗器械经营许可证申请
二、《医疗器械经营许可证》对注册地址有什么要求:
1、办公面积不少于50平方;
2、仓库面积不少于50平方;(含体外诊断试剂的需要冷冻仓库)
3、含一次性耗材的话要求办公地址和仓库面积一起不能低于150平方
注:经营场所和仓库均不得设置在居民住宅内
三、《医疗器械经营许可证》对人员有什么要求:
1、法人兼任企业负责人的需要有大专以上学历,专业不做要求;
2、质量负责人需要有3年以上工作经验,大专以上学历,相关专业毕业;
医疗器械相关专业指:医疗器械、生物医学工程、机械、电子、医学、生物工程、化学、护理学、康复、检验学、管理、计算机等专业
3、销售三类医疗器械,你必须要自己的库房,库房里需要设置冷藏库,因为三类医疗器械,是有保温需要的,超过一定的温度,就容易变质影响产品质量,很少有经销商有销售三类医疗器械的资格。
How long does it take to approve theregistration of the class III medical device license? (1)Acceptance: The applicant shall apply to the AdministrativeAcceptance Service Center, submit the application materials inaccordance with the catalogue listed in Article 6 of theInstructions, and the staff of the Acceptance Center shall examinethe application materials in accordance with the requirements ofthe Acceptance Standards for the Registration and ApplicationMaterials of Domestic Third Class and Overseas Medical Devices(National Drug Administration [2005] No.111). Where the applicationitem does not need to obtain an administrative license according tolaw, The applicant shall be informed immediately of thenon-acceptance of the application; Where the application items donot fall within the scope of the functions and powers of theadministrative organ according to law, A decision shall be madeimmediately, And inform the applicant to apply to the relevantadministrative organ;