FDA Certificate
to Foreign Government Prices and Processing Time
The FDA is authorized under the Federal Food, Drug and Cosmetic Act section 801(e)(4)(B) to charge fees when requesting a Certificate to Foreign Government for medical devices, biologics and food product.
The following prices are charged by the FDA when requesting a Certificate to Foreign Government. To obtain document apostille or embassy legalization, additional fees will be required.
Biologics products | Medical Devices | Food Products | |
---|---|---|---|
Fee for first certificate | $175.00 | $175.00 | $175.00 |
Fee for second certificate for the same product(s) issued in response to the same request | $175.00 | $85.00 | $155 |
Subsequent certificates for the same product(s) issued in response to the same request | $85.00 | $85.00 | $100.00 |
Processing Time : 20 business days if all requirements are applied |