What documents do I need to submit to get a contact lens medical device license class E? Can you send me a sample of the materials to be submitted?

Contact lenses belong to the third class of medical devices, need to apply for the "Medical Device License", you need to submit the following electronic materials, which add * for the required items.

The upload of electronic materials only supports the upload of pictures and pdf format materials.

1. *Business license and organization code certificate copy

2. * Legal representative, enterprise responsible person, quality responsible person's identity, education or title copy

3. * Organization and departmental setup description

4. * Business scope, business mode description

5. * Business premises, warehouse address Geographic location of the map, floor plan, documents proving property rights or lease agreement (with documents proving property rights)

6.* Business facilities, equipment catalog

7. * Business quality management system, work procedures and other documents

8. * Computer information management system basic information and functional description

9. * The operator Proof of authorization

10. *Scanned copy of signed and stamped application form

Sample you can download from my library.