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  1. Importing and Exporting Medical Devices

Exporting Medical Devices

Update: January 2, 2024 
 
Effective January 2, 2024, export documents for 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 authenticated by foreign governments and others using the FURLS Export Certificate Validator (FECV) for the time they are in effect. The FECV can be accessed using the internet address or Quick Response (QR) code displayed at the bottom of each certificate.

Read Electronic Export Documents – Letter to Industry.

On This Page:

Overview

Establishments exporting medical 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 certificate that is issued within 20 days.

An export certificate is a document prepared by the FDA containing information about a product's regulatory or marketing status in the 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 of 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

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

In December 2023, the FDA began transitioning from paper export documents for medical devices to electronic export documents. 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) for the time 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.

Fees

The FDA will provide you an estimate of the fee when you submit your request. 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 . Each downloadable PDF 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.

Recordkeeping

In accordance with 21 CFR 1.101(b), persons exporting a medical device under section 801(e)(1) of the Federal Food Drugs and Cosmetic Act (the FD&C Act) or an article  otherwise subject to section 801(e)(1) must maintain records as enumerated in paragraphs (1) through (4) below, demonstrating that the product meets the requirements of section 801(e)(1). 

(1) Records demonstrating that the product meets the foreign purchaser's specifications: The records must contain sufficient information to match the foreign purchaser's specifications to a particular export;

(2) Records demonstrating that the product 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 product 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 18 U.S.C. 1001; 

(3) Records demonstrating that the product 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 product does not have a shipping package or container, on shipping invoices or other documents accompanying the exported product; and 

(4) Records demonstrating that the product is not sold or offered for sale in the United States: This may consist of production and shipping records for the exported product and promotional materials.

Such records must be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product , except that records pertaining to the export of foods and cosmetics under section 801(e)(1) of the FD&C Act must be kept for 3 years after the date of exportation. The records must be made available to the FDA, upon request, during an inspection for review and copying by the FDA. 

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

Also, in accordance with 21 CFR 1.101(e)(2), these records must be kept at the site from which the devices were exported or manufactured  , and be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product. The records must be made available to the FDA, upon request, during an inspection for review and copying by the FDA.

Authentication of Export Certificates

FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV)

Effective January 2, 2024, the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) can be used to authenticate electronic export certificates issued by CDRH. Using the web address or Quick Response (QR) code displayed on each certificate, export documents can quickly be authenticated without the need to download any software or even the need for an account. The FECV displays the entire content of export certificates directly from the FDA databases, resulting in a more streamlined, secure, and trustworthy system. Using the information in FECV allows the public to confirm the validity of an export certificate. The results displayed in the FECV are the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate as well as an image of the certificate.

CDRH Export Certificate Validation Database

The CDRH Export Certificate Validation (CECV) database, which is updated once a week, can be used to verify the authenticity of paper export certificates issued by CDRH before January 2, 2024 and will remain active until January 2, 2026.  The results displayed include the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate. 

Apostille and Notarization

The FECV is recommended as the primary mode of authentication. However, electronic certificates can still be apostilled. See the Exporting Medical Devices Frequently Asked Questions (FAQs) for information on Apostille Requirements and Request for Authentications Service Form, DS-4191.  The FDA does not notarize export certificates.

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