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PAP-8E Platelet Aggregometer and Lab Tech


A Certificate to Foreign Government (CFG) is, for the export of medical devices that can be legally marketed in the United States (U.S.) that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States are required to register with FDA annually. Many establishments that are required to register with FDA also are required to list their devices.

Companies exporting products from the United States are often asked by foreign customers or foreign governments to supply a "certificate" for products regulated by the Food and Drug Administration (FDA). A certificate is a document prepared by FDA containing information about a product's regulatory or marketing status.

In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations, for example current Good Manufacturing Practice (cGMP) regulations. Review of an FDA Export Certificate may be a required part of the process to register or import a product into another country.

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FDA performs inspections for compliance with cGMP regulations for drug, biologic, medical devices, human food and animal feed manufacturers that are registered and listed with the Agency. FDA bases its attestation of compliance with cGMP regulations on the manufacturer's most recent FDA inspection and other available information. Generally, FDA cGMP regulations are intended to assure that the manufacturer can manufacture, process, package, and hold a product to assure that it meets the requirements of the Act as to safety, identity, strength, quality, and purity.  FDA's cGMP requirements for drugs are the requirements for the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug (including a biologic) to assure that such drug meets the requirements of the Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.  The cGMP requirements for devices are set forth in the quality system. The requirements govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.  Biological products, depending on their intended use, must meet the cGMP requirements for either drugs or devices.

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