1、企業名稱與經營范圍，注冊資本及股東出資比例，股東等身份證明;

2、醫療器械產品注冊證書、供應商營業執照、許可證及授權書;

3、質量管理文件等;

4、2個或以上醫學專業或相關專業人員證書、身份證明與簡歷;

5、符合醫療器械經營要求的辦公場地及倉庫證明;

6、公司章程、股東會決議等;

7、財務人員身份證和上崗證;

8、其它相道關材料。

nse, license and authorization letter; 3. 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 re of medical e; 6. Articles of association, resolutions of shareholders' meeting, etc.; 7. ID card and post card of financial personnel; 8, other phase channel clearance materials.