Under the FDA Export Reform and Enhancement Act of 1996 (EREA), medical device companies can request export certificates from the U.S. Food and Drug Administration (FDA). The cost for an initial export certificate is $175. Subsequent copies of the certificate for use in the same country are offered for a reduced fee. On August 18, 2015, FDA increased the fee for subsequent medical device export certificates from $15 to $85 to account for increased costs of processing the certificates. This marks the second time FDA has increased the fee since the export certification program began in 1996.
Export certificates issued by FDA confirm in writing the regulatory or marketing status of a device being exported to the United States. EREA directs FDA to issue export certificates within 20 days of a request. Export certificates can be requested by logging into the FDA Unified Registration and Listing Systems (FURLS) and accessing the CECATS system. Manufacturers of medical devices who wish to obtain an Export Certificate must register their establishment(s) with FDA and list all devices.
Registrar Corp can assist medical device companies to obtain an Export Certificate to Foreign Government, which can be used to offer official assurance to foreign governments that a device is in compliance with U.S. regulations as well as to assure foreign buyers of a device’s quality. Registrar Corp can also assist with FDA registration and listing requirements. For more information about FDA export certificates or other FDA regulations for medical device companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Specialist 24-hours a day at https://www.registrarcorp.com/livehelp.