Medical devices
(CECATS)

  • What is the FDA Certificate to Foreign Government for medical devices?
    • Foreign governments or businesses often request to see the Certificate to Foreign Government from enterprises that export medical devices from the United States. These devices are regulated by the Food and Drug Administration (FDA). The FDA prepares the Certificate to Foreign Government which consists of information concerning the device’s regulatory or marketing status in the U.S.

  • Why do foreign governments request the FDA Certificate to Foreign Government?
    • The governments want to be assured by the FDA that the device passed specific U.S. regulations and can be marketed in the United States. An example of tests passed by the device would be the Good Manufacturing Practice requirements, which must be adhered to before the Certificate to Foreign Governments can be issued by the FDA. When exporting these products, the Certificate to Foreign Governments will be reviewed by the foreign agency or business before the device can enter that country.

  • What is “CECATS”?
    • The Center for Devices and Radiological Health uses the CDRH Export Certification Application and Tracking System (CECATS). This is an online portal utilized by manufacturers to request export certificates for their medical devices, notifications concerning the export of these devices and export permit letters.

  • Are paper requests sent in the mail still accepted by the FDA?
    • As of October 1, 2016, paper requests are still accepted but they are converted into electronic applications by means of CECATS. Although the paper requests are accepted, the FDA advocates the use of CECATS which provides for the immediate submission of the application.

  • Where do I access CECATS and how can I contact someone if I have a problem?
    • The FDA Industry Systems page allows access to CECATS. By entering your FDA Unified Registration and Listing System (FURLS) account ID and password, you can begin the process. Read the policies and click “I understand” radio-button, then you can login.
      If you are having a problem with an export issue only, send an email to: cdrhcecats@fda.hhs.gov or you can call 301-796-7400, press option #3 when asked.

  • If our firm would like more than one account to access CECATS to apply for certificates, is that possible?
    • Yes, firms can have more than one individual as sub-accounts under their firm’s account.

CFG documents received online

Simply upload your CFG digital file, you will receive by FedEx your document processed with an apostille.

Processing time

  • expedited service
  • No need to ship your document.
  • Billing is available.
  • Credit card payment is OK.
  • US Department of State fee is included.
  • No need for the US Dept. of State form.
  • Track your history and spending online.

Exp. Service fee

US Dept. of State fee

Total:

Exp. fee

US DOS. fee

Total:

Uploading…
Done!
Error! .