Apostille Service for Certificate to Foreign Government (CFG)

A Certificate to Foreign Government (CFG) is intended 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).

step 1:

Upload your document in PDF format.

step 2:

Fill order form and verify the authenticity of your document.

step 3:

Decide method of shipping.

step 4:

Pay a total fee of $57

We, at E-Apostille, can provide you with all required work for your CFG certification. Please use our E-Apostille (Electronic Apostille) service for your Certificate to Foreign Government, by uploading your document in PDF format to our website and fill up our order form, and specify which type of mail/courier we should use to send you back the Apostilled document. This way you will save a one-way postal (or courier) service cost, and time. Generally speaking, our fees for this type of service is a fixed $62.0. After certification is complete, you can use Fedex courier service, through which we will be able to expedite your documents efficiently and safely. The cost for using Fedex service is $5.00 U.S. Dollars.

More on the CFG:

Any medical device that is legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval.

Certificate to Foreign Government Apostille

General Terms to qualify for a CFG certificate:

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. 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.

Where the CFG certificates are processed:

The Food and Drug Administration (FDA) has an office for handling and issuing such certificates. This office is called the Center for Devices and Radiological Health (CDRH). To apply for this license, CDRH uses a processing system known as “Center for Export Certification and Tracking System”, or “CECATS”. This system controls the submission, processing and awarding permissions.

How to submit a request using CECATS:

CECATS is a web-based application system for requesting export documents. This system offers several benefits, including a reduction in certificate processing time, real-time validation of firm specific data, and status updates of the request. Using CECATS, users can make changes to an export application prior to review, upload additional documents such as mailing labels, and clone (auto populate) previously submitted application information for future export requests using the “clone” icon.

Sign into your CECATS account using your account ID and password. CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS) using the establishment’s FURLS account ID and password. See Accessing CECATS and Creating a Subaccount for additional instructions on how to access the system or set up a subaccount.

Upon responding Yes to the question "Will the devices be exported from the United States?," you will be directed to the CECATS Home screen, and then you will choose the type of application you need.