How to Obtain FDA Export Certificates for Your Products

If you are a manufacturer or exporter of products that are regulated by the FDA, you may need to obtain export certificates to demonstrate that your products meet the applicable requirements of the US and the importing country. Export certificates are official documents issued by the FDA that attest to the regulatory or marketing status of a product, based on the available information at the time of issuance. They are often requested by foreign customers or governments as a condition for importing products from the US.

Different types of export certificates

There are different types of export certificates available for different products, such as food, drugs, medical devices, cosmetics, and animal products. The type of certificate you need depends on the product category, the legal status of the product in the US, and the requirements of the importing country. You should consult with your importer or the relevant authorities in the importing country to determine what type of certificate is required, if any.

How to Apply for an FDA Export Certificate Online

To request an export certificate from the FDA, you need to submit an online application through the FDA Export Certification Application and Tracking System (Certs). You will need to provide information about your product, such as its name, description, intended use, ingredients, labeling, and marketing authorization in the US. You will also need to provide information about yourself, such as your name, address, contact details, and relationship to the product. Depending on the type of certificate you are requesting, you may need to pay a fee and provide additional documentation or attestations.

Steps to obtain an FDA certificate for exporting your product

The FDA will review your application and issue an export certificate if it determines that your product meets the criteria for certification. The FDA will also verify that your product is not subject to any pending or ongoing regulatory action, such as a recall, seizure, injunction, or import alert. The FDA will send you an email notification when your certificate is ready. You can then download and print your certificate from the Certs system. You should keep a copy of your certificate for your records and send the original to your importer or foreign government.

The FDA export certificate does not guarantee that your product will be accepted by the importing country. It is still your responsibility to comply with the laws and regulations of the importing country and ensure that your product is safe and effective for its intended use. The FDA export certificate also does not preclude the FDA from taking appropriate regulatory action against your product if it violates any US laws or regulations.

If you have any questions or concerns about obtaining an FDA export certificate for your product, you can contact the FDA office that regulates your product category. You can find their contact information on the FDA website: https://www.fda.gov/industry/exporting-products-united-states/fda-contacts-exporters

FDA Export Certificates: An Overview

FDA export certificates are official documents that attest to a product’s regulatory or marketing status in the United States, based on the available information at the time of issuance. They are often requested by foreign customers or governments to facilitate the export of FDA-regulated products from the US. However, they do not guarantee that the product will be accepted by the importing country, as each country has its own laws and regulations that may differ from those of the US. Therefore, it is the exporter’s responsibility to comply with the requirements of the destination country and to consult with the relevant authorities before exporting.

FDA issues different types of export certificates for different products, such as food, drugs, medical devices, cosmetics, and animal products. The type of certificate depends on the product category, the legal status of the product in the US, and the purpose of export. Some of the most common types of export certificates are:

Certificate to a Foreign Government

This certificate is available for products that can be legally marketed in the US, such as conventional foods, food additives, food contact substances, infant formula, drugs, biologics, medical devices, and cosmetics. It states that the product meets the applicable requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and may be legally exported from the US.

Certificate of Exportability

This certificate is available for products that cannot be legally marketed in the US but can be legally exported under certain conditions, such as investigational drugs and devices, unapproved devices that meet the requirements of section 801(e) of the FD&C Act, and products intended for further manufacturing or processing. It states that the product meets the requirements of section 801(e) or 802 of the FD&C Act and may be legally exported.

Certificate of Free Sale

This certificate is available only for dietary supplements, medical foods, and foods for special dietary use. It states that the product is freely sold in the US and is not subject to any restrictions or prohibitions.

FDA charges a fee for some types of export certificates, such as Certificate to a Foreign Government and Certificate of Exportability. The fee varies depending on the number of certificates requested for the same product in response to the same request. The current fee schedule can be found on FDA’s website. FDA does not charge a fee for Certificate of Free Sale or for export certificates for animal products.

To request an export certificate from FDA, exporters can use the online application system or submit a paper application form. The online system allows exporters to create an account, submit requests, pay fees, track status, and download certificates. The paper application form can be downloaded from FDA’s website and mailed or faxed to FDA. The processing time for export certificates depends on the type of certificate, the product category, and the volume of requests. FDA aims to process most requests within 20 working days.

FDA export certificates are valid only at the time of issuance and do not imply any future approval or clearance by FDA. They also do not preclude FDA from taking any regulatory action against a product covered by the certificate if warranted. Exporters should keep in mind that FDA export certificates are not a substitute for compliance with FDA regulations or other applicable laws.

References:

https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM283299.pdf

https://www.accessdata.fda.gov/cdrh_docs/pdf3/K033391.pdf

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certification

https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates

https://www.fda.gov/medical-devices/exporting-medical-devices/types-export-certificatesfda export certificates

https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certification

https://www.fda.gov/medical-devices/exporting-medical-devices/types-export-certificates

https://www.fda.gov/about-fda/jobs-and-training-fda/buildings-and-facilities

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