What is a Certificate to Foreign Government (CFG)?
The Export Reform and Enhancement Act of 1996 authorized the Food and Drug Administration (FDA) to issue an export certificate that certifies in writing that the exported device, including radiation-emitting electronic products that are medical devices, meets certain specified requirements. The Center for Devices and Radiological Health (CDRH) is responsible for issuing those certificates for medical devices. 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 comply with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Any medical device that is legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval.
U.S. establishments may request a CFG for any medical device that may be legally marketed in the U.S. A device may be legally marketed in the U.S. if the following requirements are met:
- The establishment must be registered with the FDA;
- The device must be listed with the FDA;
- The device must have a cleared Premarket Notification [(510(k)], an approved Premarket Approval (PMA) Application (unless exempted by regulation), is a device that was on the market before May 28, 1976 (before the Medical Device Amendments to the FD&C Act), or was granted a De Novo classification;
- The device must meet the labeling requirements of Title 21 Code of Federal Regulations (CFR) Part 801 (21 CFR 801) or 21 CFR 809, if applicable;
- The device must be manufactured by the Quality System (QS) regulation of 21 CFR 820, unless exempted by regulation.
By completing the required application, an establishment certifies that:
- The establishment is registered with the FDA;
- The device is listed with FDA;
- Each device may be legally marketed in the U.S.;
- Each device is not the subject of an open recall;
- All facilities involved in the manufacturing process are in compliance with FDA’s applicable regulations; and
- Each device is being exported from the U.S.
A CFG may be requested by following the steps outlined in “How to Request Export Certificates or Permits and How to Submit Simple Notifications”.
🔎 What does a CFG look like? Click here.
How to Apostille or Authenticate a Certificate to Foreign Government Issued by FDA?
Document issued by the Department of Health and Human Services FDA division in the United States needs to be apostilled or authenticated before its use in other countries outside the United States.
Requirements for your FDA Certificate to Foreign Government
- Must be original
- Must be on agency letterhead
- Must include a legible signature of the official’s name, printed name and title, and seal of the agency
The apostille or authentication process for you is quite simple. Simply place an order below according to your situation and mail us the original document which needs apostille or authentication.