Operation Record Form of Class II Medical Devices
2. Copy of the business license of the enterprise
3 copies of the identity, education and professional title certificates of the legal representative or person in charge of the enterprise and the person in charge of quality.
4. Description of the organization and department of the enterprise.
5. A copy of the geographical location map, floor plan (indicating the actual use area), house property certificate or lease agreement (with house property certificate attached) of the business address and warehouse address of the enterprise.
6. Catalogue of commercial facilities and equipment
7 enterprise management quality management system, working procedures and other documents directory
8. Agent's authorization certificate
9. Other supporting materials
The following details: