Exporting Medical Devices

Update: July 10, 2023

In December 2023, the FDA will begin transitioning from paper export documents for medical devices to electronic export documents. For requests received on or before December 15, 2023, we will continue to issue paper certificates. For requests received on or after December 16, 2023, the FDA intends to issue paper certificates only if our review is completed prior to January 2, 2024. All certificate request reviews completed by the FDA after January 2 will be issued electronically. Export documents for human medical device products that CDRH regulates will be issued to requestors electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS). Certificates may be validated by foreign governments and others using the FURLS Export Certificate Validator (FECV) database for the time period they are in effect. The FECV will be accessed using the URL address or QR code displayed at the bottom of each certificate. The change from paper to PDF export documents will improve efficiency in issuing export documents, reduce the amount of time it takes for a manufacturer to receive export certificates or Export Permit Letters, and decrease environmental burden. Read Electronic Export Documents – Letter to Industry.

Overview

Establishments exporting devices from the United States (U.S.) are often asked by foreign customers or foreign governments to supply proof of the devices’ regulatory or marketing status as regulated by the Food and Drug Administration (FDA). The Export Reform and Enhancement Act of 1996 authorized the FDA to issue an export certificate and charge a fee for each certification that is issued within 20 working days.

An export certificate is a document prepared by the FDA containing information about a product's regulatory or marketing status in the United States (U.S.). The export certificate certifies in writing that the exported device, including radiation emitting electronic products that are medical devices, meets certain specified requirements. The requirements for exporting medical devices depend on the marketing status of the device. The marketing status indicates that the device may be legally marketed in the U.S. or cannot be legally marketed in the U.S.

The Center for Devices and Radiological Health (CDRH) is responsible for issuing export certificates for medical devices. To obtain an export certificate, a request must be submitted, and CDRH will provide approval or denial of the request. CDRH issues four types of export certificates:

Certificate to Foreign Government (CFG)
Certificate of Exportability Under Section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Certificate for Exportability Under Section 802 of the FD&C Act
Non-Clinical Research Use Only (NCR)

The FDA also processes other export documents for medical devices, including:

Export Permit Letters
Simple Notifications
Manufacturers of devices not exported from the United States, as described in section 801(e)(4)(E)(iii) of the FD&C Act, may not receive export certificates (e.g., CFGs), but may request a Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE). For more information about requesting a CFG-NE, see Devices not Exported from the United States page.

Fees

The fee for each export certificate issued from CDRH is $175.00 for the first certificate and $85.00 for each subsequent certificate from the same request. Certificates are provided on anti-counterfeit paper with an embossed gold seal.

Each certificate is limited to 25 pages (including the certificate, the manufacturers’ page and the product attachment pages). There is no limit to the number of copies of each certificate that can be requested. However, an additional $175 will be charged per 25 pages. When calculating the number of original certificates, fractions are rounded up to the next whole number.

For example: a request for 8 copies of a 10-page certificate will cost $1040 (10 pages x 8 copies = 80 pages); (80 pages / 25 = 3.2 or 4 original certificates); [($175 x 4 originals = $700) + ($85 x 4 additional certificates = $340)] = $1040.

The FDA will invoice quarterly for all certificates issued during that quarter.

There are no fees associated with export permit letters and simple notifications.

Recordkeeping

Firms exporting a device under section 801(e)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act) must maintain records demonstrating that the device meets the requirements of section 801(e)(1) and maintain the records as required by 21 CFR 1.101(b). 21 CFR 1.101(b) requires that all records must be maintained for the same period as required for records subject to the Quality System regulation requirements applicable to the device. Specifically, the Quality System regulation requires that all records must be maintained for the same amount of time equivalent to the expected life of the device, but in no case less than two years from the date of release of the device for commercial distribution by the manufacturer (21 CFR 820.180). The records must be made available to the FDA, upon request, during an inspection for review and copying by the FDA. They include records demonstrating that the device:

meets the foreign purchaser's specifications: The records must contain sufficient information to match the foreign purchaser's specifications to a particular export;
does not conflict with the laws of the importing country: This may consist of either a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, or a notarized certification by a responsible company official in the United States that the device does not conflict with the laws of the importing country and that includes a statement acknowledging that he or she is subject to the provisions of making false statements to the government under United States Code Title 18 Chapter 47, Section 1001;
is labeled on the outside of the shipping package that it is intended for export: This may consist of copies of any labels or labeling statements, such as “For export only,'' that are placed on the shipping packages or, if the exported device does not have a shipping package or container, on shipping invoices or other documents accompanying the exported device; and
is not sold or offered for sale in the U.S.: This may consist of production and shipping records for the exported device and promotional materials.

In addition to the above requirements for exporting under section 801(e)(1) when exporting devices under Section 802 of the FD&C Act, establishments shall maintain records of all devices exported and the countries to which the devices were exported. As required by 21 CFR 1.101(e), the records shall include the:

device’s trade name;
type of device;
device’s model number;
consignee’s name and address; and
date on which the device was exported, and the quantity of devices exported.

In addition, these records must be kept at the site from which the devices were exported or manufactured.

Notarization of export certificates:

The FDA does not notarize certificates. Please contact the U.S. Department of State for apostille and a certificate of authentication. You can request apostille and a certificate of authentication following the instructions at the links below:

CDRH Export Certificate Validation (CECV)

The CECV database, which is updated once a week, can be used to verify the authenticity of export certificates issued by CDRH. The results displayed include the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate.

U.S. Food and Drug Administration

Exporting Medical Devices

On This Page:

Overview

Fees

Recordkeeping

Notarization of export certificates:

CDRH Export Certificate Validation (CECV)

Resources