The request process for export certificates, permits, and simple notifications for medical devices, including radiation-emitting electronic products, is handled by the USFDA Center for Devices and Radiological Health (CDRH) in CECATS (CDRH Export Certification Application and Tracking System).

Types of Certificates/Permits Processed in CECATS

• Certificate to Foreign Government (CFG)
• Certificate of Exportability
• Non-Clinical Research Use Only Certificates
• Export Permit Letters
• Simple Notifications

CECATS Submission Process

Quick Facts to remember:

• Since January 2, 2024, all export documents for CDRH-regulated products are issued electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS).
• Foreign governments and other authorities can authenticate these certificates via the FURLS Export Certificate Validator (FECV) using the internet address or QR code displayed at the bottom of each certificate.
• Paper submissions are no longer accepted. Any mailed forms will require resubmission through CECATS.

The FDA export process for medical devices is simplified via the CDRH Export Certification Application and Tracking System (CECATS). The transition from Paper to electronic export certificates provided the manufacturers gain faster processing, real-time updates, and secure authentication via the FURLS Export Certificate Validator (FECV). Optimizing CECATS efficiently helps businesses save time, reduce administrative burdens, and maintain confidence in exporting medical devices worldwide.