3、质量管理文件等;
4、2个或以上医学專业或相关專业人员证书、身份证明与简历;
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;
s, etc.; 4,2 or more certificates, identification certificateand resume of medical professionals or related professionals; 5.Office space and warehouse certificate that meet the businessrequirements of medical equipment; 6. Articles of association,resolutions of shareholders' meeting, etc.; 7. ID card and postcard of financial personnel; 8, other phase channel clearancematerials. 2. Requirements for three-of medical device license: 1,site requirements: must be office nature, the use area should beless than 45 square meters; 2. Personnel requirements: 3 relevantpersonnel (company responsible person, quality responsible person,quality inspection personnel) need to record and hold th
