When a manufacturer of 510(k) registered medical devices ships outside of the U.S., the customer may request a Certificate to Foreign Government (CFG). This is a certificate prepared and issued by the Department of Health and Human Services. It contains information about a product’s status with the FDA. By providing the CFG, you are confirming that the medical device is approved for sale by the FDA and the device is able to be distributed in the open market without any restrictions in the United States.
The foreign government is looking for official assurance that the product being exported from the U.S. can be legally marketed within the United States and/or the product adheres to specific FDA regulations, like current Good Manufacturing Practices. In many cases, it is a requirement to provide this document in order to legally sell the product in their country.
The Certificate to Foreign Government contains a cover page, along with supplemental information. The cover page is a formal, signed document with a seal from the Department of Health and Human Services. It identifies the Certificate Number, the name and address of the manufacturer, name of product(s) to be exported, and a period of time the certificate is valid through. The “supplemental information” page(s) captures additional product details. In the case of the Bozeman facility, we list all products manufactured in our facility by product name and reorder number(s). If the customer has us create a private label product with a unique reorder number, a CFG can be created with that specific information on it.