List of documents to be submitted for FDA certification and certification cycle
List of documents to be submitted for FDA certification
1. "Entrustment Agreement" (signed by legal representative and stamped with company seal)
2, legal status certification documents (business license, business legal person code certificate, etc., photocopied with official seal)
3. Qualification certificate or production license within the validity period (copy with official seal)
4, formal application
5, Product manual
6, product technical manual
7. Product-related drawings
8. Additional documents (if any) newly required by FDA
FDA Certification cycle
The FDA certification cycle is different for different products, and the general FDA certification cycle is 10-50 working days
