大兴清源北京医疗器械三类经营许可证,医疗器械二类备案提供进销存软件库房速度快专业方便
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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。
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。
办理二类备案您需要提供:
1.法人身份信息;
2.质量员身份信息;
3.公司营业执照正副本以及公章;
4.库房地址材料;
als. 2. Requirements for three-of medical device license: 1, site requirements: must be office nature, the use area should be less than 45 square meters; 2. Personnel requirements: 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 regulations and 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 business license processing, the procedures may be more cumbersome. If you do not know what kind of product is, you can call me at any time, you can give you proper advice. For the medical qualification license, you need to have the relevant personnel, warehouse address and product number, our company can provide it for you. For Class II filing, you need to provide: 1. Legal person identity information; 2. Identity information of the quality