1、场地要求:必须是办公性质,使用面积要少达到45平方米;
2、人员要求:需要有3名相关人员(公司负责人、质量负责人、质量检查人员)的备案并且持有证书;
3、产品要求:必须要有合乎业务范围的产品信息,并出具证书;
4、其他相关法律法规要求。
三、办理三类医疗器械许可证的流程:
1、申请人提交申请资料到相关部门;
2、相关部门受理申请人的申请;
3、到实际场地进行勘察以及对产品进行审核;
4、准予颁发三类医疗器械许可证。
以上就是对三类医疗器械经营许可证办理的相关介绍,办理的程序可能较为繁琐。
如果您不知道自己的产品是什么类型的,可以打电话随时咨询我,可以给您妥善的建议。
办理医疗资质许可证,您需要具有相关的人员,库房地址以及产品编号,我司均可以为您提供。
el) need to record and hold the certificate; 3, productrequirements: must have the product information in accordance withthe business scope, and issue a certificate; 4. Other relevant lawsand regulation requirements. 3. Procedures for obtaining the ClassIII Medical Device License: 1. The applicant shall submit theapplication materials to the relevant departments; 2. Relevantdepartments shall accept the application of the applicant; 3.Investigate the actual site and audit the products; 4. Grant theissuance of a class III medical device license. The above is therelevant introduction of the three types of medical device businesslicense processing, the procedures may be more cumbersome. If youdo not know what kind of product is, you can call me at any time,you can give you proper advice. For the medical qualificationlicense, you need to have the relevant personnel, warehouse addressand product number,