FDA Medical Device Export Documents Transitioning to Electronic Format
July 10, 2023
Dear International Colleague,
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) will be transitioning to an electronic version of all export documents (certificates and letters) it issues, including the Certificate to Foreign Government, Certificate of Exportability Section 801(a) or Section 802, Non-Clinical Research Use Only Certificate, the Certificate to Foreign Government for Device Not Exported from the United States, and the Export Permit Letter.
Starting January 2, 2024, all export documents will be issued electronically, and paper certificates/letters will no longer be issued or mailed. The change from paper to electronic certificates will improve efficiency in issuing certificates, reduce the time it takes to receive export certificates, and decrease environmental burden.
All certificate and letter requests received on or before December 15, 2023, will be issued as paper. Requests received after December 16, 2023, will be issued as paper if the review is completed prior to January 2, 2024.
Manufacturers exporting human medical devices/products from the U.S. are often asked by foreign customers or foreign governments to supply an "export certificate" for products regulated by the FDA. Such certificates may provide information concerning a product’s regulatory or marketing status.
The FDA does not require export certificates to export human medical devices/products to foreign countries. Rather, these documents are intended for use by the importing countries when considering whether to license the product in question for sale in that country.
The electronic certificates (e-certificates) for human medical devices/products will be issued as downloadable Portable Document Format files (PDFs) through the CDRH Export Certification Application and Tracking System (CECATS).
How will this affect the process for submitting a request for a certificate?
The process for certificate submissions will not change. Firms will continue to use CECATS to submit certificate applications.
After January 2, 2024, how will a firm be able to request and access an export certificate electronically?
When an electronic certificate is approved, the applicant will receive an email notification containing instructions on how to access and download the e-certificate. The recipient will be able to access the e-certificate at any time via CECATS.
How can a firm or foreign government validate the authenticity of the certificates?
Foreign governments will be able to verify the authenticity of a manufacturer’s export certificate through the FURLS Export Certificate Validator (FECV) database. The FDA will add a unique Quick Response (QR) code to the e-certificate. Foreign governments can reach the FECV site by scanning the QR code on the e-certificate. The e-certificate is then verified by entering the unique certificate number on the FECV website. The agency anticipates this will enable faster exportation processing from the United States to the importing country.
Will this change the content of the export certificate?
There will be no other changes to the format or content of the certificate. The only change to the appearance of the export certificate will be the addition of the QR code.
If you have any further questions regarding this procedural change, please contact the Center for Devices and Radiological Health at cdrhcecats@fda.hhs.gov.
For more information:
The Federal Food Drug and Cosmetic Act (Sections 801 and 802)
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