8、其它相道关材料。
二、办理三回类医疗器械许可证的要求:
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。
ice license: 1, the site requirements: must be the officenature, the use of the area should be less than 45 square meters;2. Personnel requirements: 3 relevant personnel (companyresponsible person, quality responsible person, quality inspectionpersonnel) 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 regulations and requirements. 3. Procedures for obtaining theClass III 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.