CDRH Switches to Electronic for Export Documents

CDRH is now issuing electronic export documents for medical devices instead of paper to improve efficiency, reduce the amount of time it takes for a manufacturer to receive export documents, and decrease environmental burden.

All export documents will now be delivered electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS).

With the new electronic process, manufacturers will receive an email notification of approval with instructions on how to access the document. The instructions will provide one time access to print or download the document within 45 days of issuance. After 45 days, the document will no longer be available to print or download, but the certificate is valid for two years from the issue date.

Go to the FDA’s page on exporting medical devices here.

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