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).
f 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.
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