2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
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)
ce product registration certificate, supplier business license,license and authorization letter; 3. Quality management documents,etc.; 4,2 or more certificates, identification certificate andresume of medical professionals or related professionals; 5. Officespace and warehouse certificate that meet the business requirementsof medical equipment; 6. Articles of association, resolutions ofshareholders' meeting, etc.; 7. ID card and post card of financialpersonnel; 8, other phase channel clearance materials. 2.Requirements for three-of medical device license: 1, the siterequirements: must be the office n
