5、符合医疗器械经营要求的办公场地及仓库证明;
6、公司章程、股东会决议等;
7、财务人员身份证和上岗证;
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。
evice license: 1, site requirements: must be office nature, theuse area should be less than 45 square meters; 2. Personnelrequirements: 3 relevant personnel (company responsible person,quality responsible person, quality inspection personnel) need torecord and hold the certificate; 3, product requirements: must havethe product information in accordance with the business scope, andissue a certificate; 4. Other relevant laws and regulationrequirements. 3. Procedures for obtaining the Class III MedicalDevice License: 1. The applicant shall submit the applicationmaterials to the relevant departments; 2. Relevant departmentsshall accept the application of the applicant; 3. Investigate theactual site and audit the products; 4. Grant the issuance of aclass III medical device license. The above is the