1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明;

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。

nse, license and authorization letter; 3. Quality management documents, etc.; 4,2 or more certificates, identification certificate and resume of medical professionals or related professionals; 5. Office space and warehouse certificate that meet the business requirements of medical equipment; 6. Articles of association, resolutions of shareholders' meeting, etc.; 7. ID card and post card of financial personnel; 8, other phase channel clearance materials.