US FDA Moves to Electronic Formats for Medical Device Export Documents

The US Food and Drug Administration (FDA) has begun issuing export documents for medical devices in electronic format in order to help streamline processes and reduce time and effort for manufacturers seeking to sell their products in non-US markets.

A letter to industry from FDA explains that the agency’s transition to electronic formats took effect January 2, 2024, and applies to documents such as Certificates to Foreign Government (CFG), Certificates of Exportability (COE) and Non-Clinical Research Use Only Certificates (NCR). FDA now also issues Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) as well as Export Permit Letters via electronic format.

Access to documents via CDRH application and tracking system

FDA’s Center for Devices and Radiological Health (CDRH) now delivers export documents as downloadable PDFs via the CDRH Export Certification Application and Tracking System, or CECATS. Manufacturers have 45 days to print or download documents once they’ve received email notification from FDA that their documents are approved and available.

Stakeholders engaged in medical device exporting activities should be aware that documents that include apostilles, authentications and/or notarizations must be printed in color to be valid.

Streamlined access for foreign governments and regulators

Foreign governments, regulatory agencies, device distributors and other stakeholders may now verify authenticity of FDA-issued export certificates and documents using the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) tool during the time periods for which such documents are valid. Access to the FECV is available by scanning QR codes included on electronic export documents.