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  1. Importing and Exporting Medical Devices

Exporting Medical Devices

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 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 certificates:

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

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

  • Export Permit Letters
  • Simple Notifications

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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, $175 will be assessed per 25-page increment. 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.

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

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

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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 801(e)(1) 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 devices meet the foreign purchaser's specifications: The records must contain sufficient information to match the foreign purchaser's specifications to a particular export;
  • Records demonstrating that the devices 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;
  • Records demonstrating that the device is labeled as intended 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
  • Records demonstrating that the device 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;
  • The type of device;
  • The device’s model number;
  • The consignee’s name and address; and
  • The 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.

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Notarization of export certificates:

As of March 2014, 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:

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CDRH Export Certificate Validation (CECV)

The CECV database, which is updated once a week, can be used to verify 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.

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