As mentioned in our article about the Equivalency Agreement and our Ultimate Guide for Regulatory Affairs in Mexico, one of the choices you have to register a Medical Device for its sale and distribution in Mexico is the Equivalency Agreement route. In this regulatory pathway, one of the key documents for the FDA Equivalency route is the Certificate to Foreign Government (CFG), which provides information about the manufacturer, distributor, and the cleared products. Nevertheless, the FDA has published updates related to this certificate.
Specifically, on December the 29th 2022, the Consolidated Appropriations Act 2023 was enacted. This Act directs the FDA to provide certification for devices that are not exported from the United States, in the form of the so-called Certificate to Foreign Government for Device Not Exported from the United States, or CFG-NE.
In this article, we aim to give you a brief introduction to this document, as well as a summary on what is necessary to procure said certificate and our comments about using it in the Equivalency Agreement process in Mexico.
What is a CFG-NE?
The Certificate to Foreign Government (CFG) serves as a document indicating that the products referred in such document:
- Are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act;
- Can be legally marketed in the United States;
- May be exported anywhere in the world without prior FDA notification.
On the other hand, the Certificate to Foreign Government for Device Not Exported from the United States, or CFG-NE, is a new certification method. Parallel to the CFG, the CFG-NE is thought for medical devices that are manufactured outside the United States, but due to regulatory requirements in other countries, still need that FDA compliance.
The CFG-NE consists of a document that can be issued to medical devices, that are cleared, approved, or are not required to submit a premarket report, and are shipped from outside the United States to another foreign country.
Requirements for obtaining a CFG-NE
In order to request a CFG-NE, it is necessary to provide a set of certified information. The full set of official requirements and procedures can be consulted at the FDA official page. A brief summary of those requirements:
- The first set of requirements focus on the medical devices manufacturers. The manufacturers pursuing a CFG-NE must be located outside the U.S., registered under section 510 of the FD&C Act, and must enlist every medical device that they manufacture.
- The second set of requirements focus on the devices. Each product must be authorized to be marketed within the U.S. and must possess a premarket notification under section 510(k) of the FD&C Act. They also need to be imported or offered for importation into the U.S., and need to be free of being a subject of an open import alert, recall, seizure, injunction or any other open enforcement action.
- Another set of requirements states that manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified. Finally, that the requesting establishment and all establishments involved in the manufacturing process are operating in substantial compliance with the Current Good Manufacturing Practices Requirements for all the identified devices.
It is important to note that COFEPRIS has not issued an official stance yet regarding the regulatory pertinence of the CFG-NE. If you intend to use this certificate for your regulatory needs in Mexico, feel free to contact us at firstname.lastname@example.org for further guidance or fully counseled analysis.