1. "Class II Medical Device Business Registration Form";
2. "Class II Medical Device Business Enterprise Registration Application Material Checklist";
3. Copy of the enterprise's "Business License" (original for verification);
4. Copies of identity certificates, academic qualifications or professional title certificates of the legal representative, the person in charge of the enterprise, and the person in charge of quality;
5. The organizational structure and functions of the proposed enterprise or the functions of full-time quality management personnel;
6. The geographical location map and floor plan of the proposed enterprise’s business premises and warehouse address (indicate the use area), a copy of the property rights certificate or lease agreement (with the property rights certificate of the leased house, the same below);
7. Proposed enterprise product management quality management system documents and work procedures (only for in vitro diagnostic reagent wholesale Enterprise) and catalog of storage facilities and equipment;
8. Copy of authorization certificate and identity certificate of the person in charge;
9. Other supporting materials.