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 are in compliance 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 prior to 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 in accordance with 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.
1. Order the Apostille service online.
▶️ If the destination country is a member of the Hague Convention of 1961, it needs to get an Apostille certificate. Once the apostille is completed, It is ready for use.
▶️ However, if the destination country is NOT a member of the Hague Convention of 1961, more steps are needed. Specifically, the document needs to be authenticated by the U.S. Department of State, and the embassy of that destination country which is located in Washington D.C.
2. Mail your original documents to our office for processing.
Mailing Address:
American Notary Service Center
7512 Diplomat Drive, Suite 101,
Manassas, VA 20109Besides CFG, we can also apostille documents issued from other states, D.C., or the U.S. Federal agencies. The Apostille process can be complicated, time-consuming, and distracting that requires expertise and experience. So leave it to us! Our experts can provide you with a full range of fast services that allow you to save time and focus on your own careers and key areas.
American Notary Service Center Inc. provides fair, fast, confidential, and professional document notarization and certification services for our clients. We also provide various assistance services to small businesses led by socially and economically disadvantaged groups. Our service helps small businesses obtain federal government contracts, gain a foothold in the market, and boost their sales. For more information, please visit our website at www.usnotarycenter.com, and contact us by calling 202-599-0777 or by email at info@usnotarycenter.com.