Transition to Electronic Export Documents
The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has transitioned from paper to electronic export documents for medical devices.
Starting January 2, 2024, certificates like CFG, COE, and NCR will be electronically issued as downloadable PDFs via CECATS.
Recipients have 45 days to access and print the document.
Verification can be done through the FDA’s FECV system using a QR code, and certificates remain valid for 2 years.
Electronically issued documents include:
- Certificate to Foreign Government (CFG);
- Certificate of Exportability (COE) under section 801(e)(1) or 802 of the Food, Drug, and Cosmetic Act (the FD&C Act);
- Non-Clinical Research Use Only Certificate (NCR);
- Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE); and
- Export Permit Letter
Any queries regarding electronic export documents for medical devices, please email to Exportcert@cdrh.fda.gov.