2. business quality management system, work procedures and other documents directory (copy 1; material requirements: paper and electronic)
3. geographical location of the business premises, warehouse address, the Indoor floor plan (1 copy; material requirements: paper and electronic)
4. Medical device license application form (1 original; material requirements: paper and electronic)
5. The person in charge of the enterprise's academic qualifications or professional title certificate (1 original; 1 copy; material requirements: paper and electronic)
6. Business facilities and equipment catalog ( Copy 1; Material requirements: paper and electronic)
7. Legal representative, the person in charge of the enterprise, the person in charge of quality of identification (1 original; copy 1; Material requirements: paper and electronic)
8. Industrial and commercial business license (copy 1; Material requirements: paper and electronic)
9. Proof of authorization of the operator (original; (Material requirements: paper and electronic)
10. quality of the person in charge of the academic qualifications or title certificate (1 original; 1 copy; Material requirements: paper and electronic)
11. business premises, warehouse address of the house property rights documents or lease agreement (copy; Material requirements: paper and electronic)
12. computer Information management system basic information and functional description (1 copy; material requirements: paper and electronic)
13. Legal representative of the academic certificate or certificate of title (1 original; 1 copy; material requirements: paper and electronic)
14. Enterprise organization and departmental setup instructions (1 copy; material requirements: paper and electronic)