1. "Entrustment agreement" (legal representative signed, stamped with the company seal)

2. Legal status certificate (business license, business card, etc., copy the official seal

3. Qualification certificate or production license within the validity period (photocopying official seal)

4. Formal application

5. Product brochure

6. Product technical manual

7. Product related drawings

8.FDA adds additional documents (if any) to be submitted