Apostille Certificate to Foreign Government

  • A Certificate to Foreign Government is a legal document that is used to export pharmaceuticals
    and medical devices manufactured and sold in the United States. The government agency that issues this
    kind of certification is the Food and Drug Administration (FDA).
  • If your company exports products to a Hague Convention member country, the destination country’s
    government will demand a Certificate to Foreign Government, which guarantees that the product complies with US laws and regulations.
  • Medical devices that are legally advertised in the United States can be exported to any country in
    the world without the need for FDA approval. Although the FDA does not limit the export of legally
    sold goods, certain importing countries require FDA certification that the firm or its devices comply with
    U.S. FDA regulations. The foreign government will request official confirmation that the products exported to
    their countries comply with US FDA regulations such as Good Manufacturing Practice (GMP) requirements. In such cases,
    a US company should apply for a certificate from a foreign government (CFG).

CFG Requirements:

  • The foundation must be FDA-registered.
  • The FDA must approve the device.
  • The device must have a cleared Premarket Notification [(510(k)] or an approved Premarket Approval (PMA) Application (unless excluded
    by regulation), be a device that was on the market before May 28, 1976 (before the Medical Device Amendments to the FD&C Act), or
    be classified as De Novo.
  • If applicable, the device must comply with the categorizing requirements of Title 21 Code of Federal Regulations (CFR) Part
    801 (21 CFR 801) or 21 CFR 809;
  • the device must be manufactured following the relevant System (QS) regulation of 21 CFR 820 unless excluded by regulation.

FDA documents received by mail Regular Service

Fee

Processing time

  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received by mail Expedited Service

Fee

Processing time

  • Billing is available.
  • Shorter processing time.
  • Credit card payment is OK.
  • No need for the US Department of State form.
  • Return FedEx or UPS is required, or add $12.
  • Track your history and your annual spending online
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FDA documents received online Regular Service

Fee

Processing time

  • Must be paid by a check or money order.
  • Must include UPS or USPS Return.
  • Must fill the US Department of State form.

FDA documents received online Expedited Service

Fee

Processing time

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  • No need to ship your document. You may upload it here.
  • Billing is available.
  • Shorter processing time.
  • 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.