Since January 2, 2024, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) began issuing electronic export documents for medical devices. The change from paper to electronic PDF improves efficiency in issuing export documents, reduces the amount of time it takes for a manufacturer to receive export documents, and decreases environmental burden.
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.
💡 The issuance of an electronic certificate does not result in any changes to the format or content of the certificate.
If you have any questions regarding electronic export documents for medical devices, please email Exportcert@cdrh.fda.gov.
How to Apostille or Authenticate the electronic or digital FDA documents?
Step 1. Apply for and download the document from the FDA's website.
All export documents issued by CDRH on or after January 2, 2024, will be delivered electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS). With the new electronic process, you will receive an email notification of approval with detailed instructions on how to access the document. One time access will be granted 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.
Step 2. Order the Apostille or Authentication service based on the destination country.
▶️ If the destination country is a member of the Hague Convention of 1961, it needs to get the Apostille from the Secretary of State. Once the apostille is completed, It is ready for use.
▶️ If the destination country is NOT a member of the Hague Convention of 1961, more steps are needed. Specifically, the document needs to be authenticated by the U.S. Department of State, and the embassy of that destination country which is located in Washington D.C.
Step 3. Upload the electronic FDA documents.
That's all from your end. We'll process the document as soon as possible. After apostille or authentication, it will be shipped to your mailing address.
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Besides documents issued by the FDA, we also provide apostille, authentication, and embassy legalization services for other personal documents and corporate documents issued in 50 states and DC.
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