Medical Devices

How to Request Export Certificates/Permits and Submitting Simple Notification

Export communications with the FDA depend on the conditions under which the export is taking place. Communications include:

Requests for the export documents listed above can be requested through the CECATS system. CECATS is a voluntary electronic system that allows manufacturers and initial importers to request export documents online as an alternative to paper submissions. The system offers several benefits, including a reduction in certificate processing time, savings on material and mailing costs for paper applications, real-time validation of firm-specific data, and status updates for the request.

CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS). Firms must have a FURLS account ID and password to access this system. Consult the “New User” section of the FURLS website for instructions on setting up an account.

Export Certificates

Costs

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

Each certificate is limited to 25 pages (including the certificate, the manufacturer page and attachment pages). There is no limit to the number of copies 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.

There are no fees associated with export permits and simple notification.

Timeframe

FDA shall issue certificates within 20 business days if the applicable requirements are met.

Exporter’s Certification Statement

All establishments that are to be listed on the final certificates must provide a signed Exporter’s Certification Statement. The document is found in the appropriate paper request packet. If applying electronically, these document(s) are uploaded in section 9. No changes to the body of text are permitted. Firms may indicate their role, such as Contract Manufacturer, beside the firm name.

Shipping Label

Please provide a prepaid UPS or FEDEX label for the FDA to send your certificates to you once they are printed. No FEDEX Ground labels are accepted. The label should be self-addressed to a U.S. location. If applying electronically, you will be asked to upload this document in section 9.

Certificate to Foreign Government

In many cases, foreign governments will seek official assurance that products exported to their countries are in compliance with U.S. law or meet specific U.S. regulations, such as Quality System Regulations (QSR) (also known as Good Manufacturing Practice requirements). In these cases, firms may submit a Certificate to Foreign Government request to FDA.

There are two options for submitting a request for a Certificate to Foreign Government:

  • Electronically via CECATS: choose the Certificate to Foreign Government (CFG) option. If you have any questions regarding using CECATS for your request please email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3. A reviewer will promptly reply to assist.
  • Paper via mail: use CFG FDA-3613 form and mail it according to the directions on the form. If you have any questions regarding this process please email exportcert@cdrh.fda.gov or call 301-796-7400 and select option 3.

Certificate of Exportability under Section 801(e)(1)

Even though the FDA does not require a firm to obtain written permission prior to export under section 801(e)(1), a foreign purchaser may request proof of compliance with U.S. law prior to export. The FDA implemented a certification process referred to as a Certificate of Exportability (COE) to facilitate export of unapproved medical devices under section 801(e)(1).

Exporters applying for a COE are required to sign a statement indicating that they meet the criteria of 801(e)(1). False statements are violations of United States Code Title 18, Chapter 47, Section 1001.

There are two options for submitting a request for a Certificate to Foreign Government:

  • Electronically via CECATS: choose the Certificate of Exportability 801 option. If you have any questions regarding using CECATS for your request, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3. A reviewer will promptly reply to assist.
  • Paper via mail: use FDA-3613a form and mail it according to the directions on the form. If you have any questions regarding this process please email exportcert@cdrh.fda.gov or call 301-796-7400 and select option 3.

Certificate of Exportability under Section 802

Even though the FDA does not require a firm to obtain written permission prior to export under section 802, a foreign purchaser may request proof of compliance with U.S. law prior to export. The FDA will provide a COE to the exporter under section 802 to facilitate export of a medical device.

Exporters applying for a COE are required to sign a statement indicating that they are exporting legally under the provisions of section 802. False statements are violations of United States Code Title 18, Chapter 47, Section 1001.

There are two options for submitting a request for a Certificate of Exportability under section 802:

  • Electronically via CECATS: choose Certificate of Exportability 802 option. If you have any questions regarding using CECATS for your request, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3. A reviewer will promptly reply to assist.
  • Paper via mail: use FDA-3613a form and mail it according to the directions on the form. If you have any questions regarding this process, please email exportcert@cdrh.fda.gov or call 301-796-7400 and select option 3.

Non-Clinical Research Use Only Certificate

While FDA permission is not required when exporting a non-clinical research use only product, the FDA will supply firms with a certificate upon request. The Non-Clinical Research Use Only Certificate is for the export of non-clinical research use only products, materials, or components not intended for human use, which may be marketed in, and legally exported from, the United States under the Federal, Food, Drug, and Cosmetic Act.

There are two options for submitting a request for a Non-Clinical Research Use Only Certificate:

  • Electronically via CECATS: choose the Non-Clinical Research Use Only Certificate option. If you have any questions regarding using CECATS for your request, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3. A reviewer will promptly reply to assist.
  • Paper via mail: use FDA-3613a and mail it according to the directions on the form. If you have any questions regarding this process, please email exportcert@cdrh.fda.gov or call 301-796-7400 and select option 3.

Export Permit Letter via Section 801(e)(2)

To obtain an Export Permit Letter, which affirms the FDA's approval to export devices in accordance with section 801(e)(2) of the FD&C Act, a request should include the following information:

  • A complete description of the device intended for export;
  • The status of the device in the U.S., e.g., whether it is investigational, banned, etc.,
  • A statement indicating that the requestor conducted a search of the Medical Literature Analysis and Retrieval System database (see instructions below) and a summary of the search results, as well as a summary of safety data to demonstrate that export of the device will not endanger the public health and safety, or documentation of exemption from this requirement (see below), and
  • A letter from the appropriate foreign liaison (person with authority to sign a letter of acceptance for the foreign government) identified in the CDRH Foreign Liaison Listing, which must be either in English or accompanied by a certified English translation, stating that:
    • The device is not in conflict with the laws of the country to which it is intended for export;
    • The foreign government has full knowledge of the status of the device in the U.S.; and
    • Import is permitted or not objected to.

If the manufacturer is exporting a device with a “CE” mark to a country within the European Economic Area, FDA will accept documentation of receipt of the CE mark in lieu of a letter from the foreign government approving importation.

Searching the U.S. National Library of Medicine (NLM) Databases

There are two circumstances in which FDA does not request a search of the NLM databases and submission of safety data with an export request:

  • The device has an FDA-approved Investigational Device Exemption and will be marketed or used for clinical trials in the importing country for the same intended use; or
  • The manufacturer has been informed by two Institutional Review Boards in the U.S. that the device is a non-significant risk device and the device will be marketed or used for clinical trials in the importing country for the same intended use.

In all other cases, the FDA requires that the requester conduct searches of the NLM databases and provide safety data. As noted above, FDA requires a summary of search results for most requests under section 801(e)(2).

The FDA does not have an estimated timeframe for responding to export permit requests.

There are two options for submitting a request for an Export Permit Letter under section 801(e)(2):

  • Electronically via CECATS: choose the Export Permit Letter option. If you have any questions regarding using CECATS for your request, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3. A reviewer will promptly reply to assist.
  • Paper via mail: submit your request via mail to the address below. If you have any questions regarding this process please email exportcert@cdrh.fda.gov  or call 301-796-7400 and select option 3.

Food and Drug Administration
CDRH - Office of Compliance
Export Certificates
10903 New Hampshire Avenue
Building 66 Room 2621
Silver Spring, MD 20993-0002
Telephone number: 301-796-7400

Questions regarding this process should be sent to: exportcert@cdrh.fda.gov

Simple Notification to the FDA for Exporting via Section 802

While the FDA does not require a firm to obtain written permission prior to export under section 802, firms exporting a device under section 802 must provide written notification to the FDA.

The notification must identify:

  • The product's trade name;
  • The type of device;
  • The product's model number; and
  • The country that is to receive the exported product if the export is to a “not listed” country (non-Tier 1 country).

If the export is intended for a “listed” Tier 1 country, then the notification may, but is not required to, identify the importing country. Or it may state that export is to a Tier 1 country without identifying the listed country.

There are two options for submitting a Simple Notification under section 802:

  • Electronically via CECATS: choose the Simple Notification option. If you have any questions regarding using CECATS for your request, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3. A reviewer will promptly reply to assist.
  • Paper via mail: submit your simple notification via mail to the address below. If you have any questions regarding this process please email exportcert@cdrh.fda.gov or call 301-796-7400 and select option 3.

Food and Drug Administration
CDRH - Office of Compliance
Export Certificates
10903 New Hampshire Avenue
Building 66 Room 2621
Silver Spring, MD 20993-0002
Telephone number: 301-796-7400

 

Page Last Updated: 09/01/2015
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