Manufacturers that export FDA-regulated products such as drugs and medical devices from the US are oftentimes required to provide a certificate prepared by the FDA which confirms the product’s regulatory and marketing status...

1. FDA Export Certificates
By: Nikita Angane
Manufacturers that export FDA-regulated products such as drugs and medical devices from
the US are oftentimes required to provide a certificate prepared by the FDA which confirms the
product’s regulatory and marketing status.1
In most cases, the foreign regulatory body requires an official assurance that the products
being imported into their country from the United States have received the appropriate marketing
authorization and follow GMP regulations of its country of origin.1
Upon the company’srequest, FDA will issue such certificatesfor human drugs and biologics,
animal drugs, and devices that either may be legally marketed in the United States or may be legally
exported, althoughthey may not be legally marketedin the United States. FDA is not requiredto issue
such certificates for food, animal feeds, dietary supplements, or cosmetics. However, whenever a
foreign regulatory authority may require such certificates, the FDA will issue them as resources
permit.1
FDA bases its attestation of compliance on the firm’s most recent inspection by the FDA, its
compliance history with the FDA, and other such information. FDA will not issue a certificate when:1
 FDA has initiated an injunction or a seizure for that product
 The manufacturer does not operate within cGMP regulations
 The facility is not registered and the product is not listed with the FDA
 When the product is not going to be exported from the US
The following are the types of certificates offered by the FDA for medical devices:1
 Non-clinical Research Use Only Certificate: For export of a product for non-clinical
research purposes only
 Certificate to ForeignGovernment:For the export of medicaldevicesthat canbe legally
marketed in the US
 Certificate of Exportability: For the export of devices that cannot be legally marketed
in the United States but may be legally exported.
FDA may charge a fee of up to $175 if the FDA issues a certificate within 20 government
working days, but will not exceed $175.1
Are youlookingto export your medicaldevice andneed help? Call us today at +1 248-987-
4497 or email us at info@emmainternational.com to know more.
1 FDA (July2004) FDA Export Certificates retrieved on11/11/2020 from https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/fda-export-certificates