- 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).
- 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.
Apostille Certificate to Foreign Government
FDA Apostille provides attestation service for Certificate to Foreign Government issued by US Food & Drug Administration and destined for use in the Hague Convention Participating Countries. We obtain Apostille for Certificate to Foreign Government from the US Department of State in Washington DC.
Certificate to Foreign Government Legalization
FDA Apostille assists corporations to authenticate Certificate to Foreign Government from the US Department of State and the embassy of the destination country in Washington DC. Embassy legalization is required to acknowledge documents destined for use in the Non-Hague Participating Countries.