FDA Registration

Are you a Domestic and Foreign manufacturer? If yes, your establishment(s) that manufacture, repack, or re-label any of the following products such as Animal and Veterinary drugs, Cosmetics, Drugs, Medical Devices, Radiation-Emitting Products, Tobacco Products, Vaccines, Blood, Biologics in the United States are required to register with the FDA. This process generally called as FDA Registration or FDA Establishment Registration.

FDA Registration can be done online. In case of foreign manufactures they need the help of US Agent for completing the FDA Registration. We act as US Agents for completing the registration. The annual FDA registration has to be completed by renewing the FDA agent agreement.

FDA Registration for Foreign Food Manufactures And Exporters

Timeline: TWO hours

FDA Food Registration Fees: Nil

US Agent Fees : 400 USD Yearly

FDA Certificate: 100 USD

FDA Food Label Review: 800 USD in 20 days

FDA Registration for Drug / API / Analytical Facilities

Timeline: 4 Days

FDA Drug Establishment Registration Fees: Nil

US Agent Fees : 700 USD Yearly

FDA Certificate: 100 USD

Listing Fees: 500 USD

FDA Registration for Medical Device Facilities

Timeline: 14 Days

Medical Device FDA Registration Fees: Nil

US FDA Fees: 4884 USD Yearly

US Agent Fees : 500 USD Yearly

Listing Fees: 500 USD

FDA Registration for Cosmetics Products ( VCRP)

Timeline: 15 Days

FDA Cosmetic Registration Fees: Nil

US Agent Fees : 700 USD

Ingredient Statement Filling : 700 USD

We issue Certificate after completing the FAD Registration. Our FDA Certificate is NOT approved by US FDA. ( US FDA never approve or accept third party certificates)

For more information and application form for US FDA Registration and listing, please email to enquiry@meddevicecorp.com

US FDA Registration Services

We help Manufacturers, Distributors, Exporters to REACH USA MARKET

Food Facility Registration and US Agent Service

Initial year US Agent Fees – 450 USD and renewal(s) 150 USD.

We charge 700 USD for the label review (Optional Service)

Medical Device Registration, Listing & US Agent Service

Initial year US Agent Fees – 650 USD and renewal(s) 350 USD

Each Device Listing – 100 USD ( one time only)

We charge 700 USD for the label review (Optional Service)

Drug Registration, Listing & US Agent Service

[OTC, Prescription, API, Veterinary, Homeopathic]

Initial year US Agent Fees – 700 USD and renewal(s) 450 USD

Each Drug / Each Dosage Form Listing – 500 USD ( one time only)

We charge 700 USD for the label review (Optional Service)

Contact us for more information enquiry@meddevicecorp.com