CERTIFICATE TO FOREIGN GOVERNMENTS
Bio/Data Ensures Compliance and Facilitates Global Exports with FDA Registration and Certificate to Foreign Government (CFG) Accreditation
Bio/Data not only registers our products with the FDA but also holds Certificate to Foreign Government (CFGs). A CFG is essential for exporting medical devices that are legally marketable in the United States (U.S.) and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements.
Bio/Data not only registers our products with the FDA but also holds Certificate to Foreign Government (CFGs). A CFG is essential for exporting medical devices that are legally marketable in the United States (U.S.) and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements. Businesses involved in producing and distributing medical devices for U.S. use must annually register with the FDA, and many of these establishments must also submit a comprehensive list of their devices. This dual registration and listing process ensure that our products not only meet U.S. standards but also comply with international regulations, facilitating smooth exports to other countries.
Companies exporting goods from the United States are frequently requested by foreign customers or governments to furnish a "certificate" for products subject to regulation by the Food and Drug Administration (FDA). This certificate is a document created by the FDA and contains information regarding the regulatory or marketing status of a product.
Companies exporting goods from the United States are frequently requested by foreign customers or governments to furnish a "certificate" for products subject to regulation by the Food and Drug Administration (FDA). This certificate is a document created by the FDA and contains information regarding the regulatory or marketing status of a product.
In numerous instances, foreign governments seek official assurance that products destined for their countries can conform to U.S. regulations, such as the current Good Manufacturing Practice (cGMP) regulations. The review of an FDA Export Certificate is often a mandatory step in the process of registering or importing a product into another country.
The FDA conducts inspections to assess compliance with cGMP regulations for manufacturers of drugs, biologics, medical devices, human food, and animal feed that are registered and listed with the Agency. The FDA's verification of compliance with cGMP regulations is based on the manufacturer's most recent FDA inspection and other available information. Generally, FDA cGMP regulations aim to ensure that the manufacturer can produce, process, package, and store a product to guarantee its adherence to the Act's requirements concerning safety, identity, strength, quality, and purity.
The cGMP requirements for drugs encompass the methods and facilities or controls employed in the manufacture, processing, packing, or holding of a drug (including a biologic). This ensures that the drug meets the Act's requirements for safety, possesses the stated identity and strength, and meets the declared quality and purity characteristics. For devices, the cGMP requirements are outlined in the quality system, governing the methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Depending on their intended use, biological products must adhere to the cGMP requirements for either drugs or devices.