Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) is document issued by FDA issued for legally marketed devices in the U.S that are manufactured by the companies located outside of the United States and are in compliance with the regulations of FD&C act.
Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is not being exported from the U.S.
Requirements to get the Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE)
- The manufacturing facility must have a valid medical device establishment registration and must be located outside of the United States.
- All devices must be listed with the FDA.
- The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
- The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
- The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.
- Each device(s) identified is not the subject of an import alert, recall, seizure, injunction, or the subject of any other FDA enforcement action.
- Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified
Certificate to Foreign government can be requested through CECATS system. It is a voluntary electronic system that allows the manufacturers to request export documents online. CECATS can be accessed by logging into the FDA Furls account.
The fees for export certificate from CDRH are $175 for the first certificate and $85 each for additional certificate upon the request from the customer.
Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us