FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
FDA Export Certificate
Click the button below to see the service steps in an easy-to-follow graphic format.
What is an FDA Export Certificate?
An FDA Export Certificate is an official document issued by the U.S. Food and Drug Administration that certifies a product’s regulatory or marketing status based on information available at the time of issuance. Certificate types vary by product category and export purpose and may include a Certificate to Foreign Government (CFG), a Certificate of Free Sale (CFS), a Certificate of Exportability, or a Certificate of a Pharmaceutical Product.
Companies may request an FDA Export Certificate for eligible FDA-regulated products, including foods, dietary supplements, drugs, medical devices, and certain other products. Foreign regulators, distributors, or customers may require these certificates for product registration, import clearance, or market access. The applicable certificate type and eligibility depend on the product’s FDA regulatory status and the requirements of the relevant FDA center.
FDA Export Certificates vary by product category and may include different regulatory, marketing-status, or facility information depending on the product being exported. The applicable FDA center manages the certificate process, which may include CBER, CDER, CDRH, CFSAN, or CVM.
Who can obtain an FDA Export Certificate?
- Food and Beverages: Includes conventional foods, dietary supplements, and ingredients.
- Pharmaceuticals: Encompasses both prescription and OTC drugs.
- Medical Devices: Range from Class I simple devices to Class III, such as MRI machines.
- Cosmetics: Covers skincare, makeup, and personal care products.
- Veterinary Products: Includes animal drugs, feeds, and devices.
- Biologics: Includes vaccines, blood products, and gene therapy products.
- Tobacco Products: Encompasses cigarettes, cigars, and other tobacco-based products.
FDA issues different export certificates based on the type of FDA-regulated product and its U.S. marketing status. Each certificate has a specific title, purpose, and FDA-approved format. The available certificate types are listed below.
Certificate to Foreign Government (CFG): issued for exporting human food, human drugs, animal drugs and feed, and medical devices that meet the applicable marketing requirements in the United States.
Certificate of Exportability: This document allows the legal export of food, human drugs, animal drugs and feed, and medical devices not approved for marketing in the United States but comply with the requirements of sections 801 or 802 of the FD&C Act.
Certificate of a Pharmaceutical Product (CPP): This certificate is for human and animal drugs. It follows the format set by the World Health Organization (WHO) and is commonly used by the importing country to assess whether to approve the drug for sale within that country.
Certificate for Cosmetics: This certificate is issued for products that meet the US definition of cosmetics. It cannot be issued for products that make therapeutic claims on their label, such as cleansers marketed for acne treatment.
Certificate of Free Sale (CFS): issued for human dietary supplements, medical foods, foods for particular nutritional use consumption, animal food, animal drugs, or medicated animal feed that are regulated by the FDA and can be legally marketed in the United States.
Health Certificate: Foreign governments may request health certificates for human foods with animal-derived ingredients, often seeking FDA statements on compliance with foreign regulations. Generally, the FDA does not issue certificates confirming compliance with another country’s requirements but may work with other governments to create acceptable language for health certificates, such as those for collagen or gelatin products exported to the EU. Requests for new health certificates are considered on a case-by-case basis.
What Conditions Prevent The FDA From Issuing An Export Certificate?
The FDA reviews records for relevant establishments and products when deciding whether to issue export certification. The FDA will only issue the certification if it finds that the establishments or products are eligible, such as noncompliance with CGMP, lack of proper registration and listing, or enforcement actions in place.
Is there any Fee Involved to Obtain an Export Certificate?
The FDA charges a fee for export certifications for human food, human drugs, animal food, animal drugs, medicated animal feed, and medical devices if the certification is issued within 20 days of receiving a complete request. This fee may vary depending on the product type.
How We Help You Obtain an FDA Export Certificate ?
FDA Listing Inc. can help you obtain an expert certificate for your product. Before we do so, we gather information to verify whether you qualify to receive the export certificate.
Eligibility Review: We evaluate your product and determine certificate eligibility.
Document Preparation: We assist with label reviews, facility registration, and U.S. agent services.
FDA Submission: We file the certificate request with the FDA on your behalf.
Follow-Up & Delivery: We track the status and send your approved certificate via courier or digital download.
Let us help you navigate the FDA export certification process with confidence; please call or email us for assistance.
Service Details & Fees
FDA Export Certificate
Time Required
FDA Registration Verification
Discount on Services (15-25%)
495 USD
2 Days
_______ Related Services _______
Service Details & Fees
FDA Export Certificate
495 USD
Time Required (Filing)
2 Days
FDA Registration Verification
Discount on Services (15-25%)
_______ Related Services _______