北京亦庄北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富速度快靠谱
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。
3 relevant personnel (company responsible person, quality responsible person, quality inspection personnel) need to record and hold the certificate; 3, product requirements: must have the product information in accordance with the business scope, and issue a certificate; 4. Other relevant laws and regulation requirements. 3. Procedures for obtaining the Class III Medical Device License: 1. The applicant shall submit the application materials to the relevant departments; 2. Relevant departments shall accept the application of the applicant; 3. Investigate the actual site and audit the products; 4. Grant the issuance of a class III medical device license. The above is the relevant introduction of the three types of medical device