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  5. Exporting Medical Devices
  6. How to Request Export Certificates or Permits and How To Submit Simple Notifications
  1. Exporting Medical Devices

How to Request Export Certificates or Permits and How To Submit Simple Notifications

Overview

CDRH processes requests for certificates or permits and submissions of simple notifications for the exportation of medical devices, including radiation emitting electronic products. The CDRH Export Certification Application and Tracking System (CECATS) is used to process these requests and submissions.

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How to submit a request using CECATS

CECATS is a web-based application system for requesting export documents. This system offers several benefits, including a reduction in certificate processing time, real-time validation of firm specific data, and status updates of the request. Using CECATS, users can make changes to an export application prior to review, upload additional documents such as mailing labels, and clone (auto populate) previously submitted application information for future export requests using the “clone” icon.

To submit a request using CECATS:

  • Sign into your CECATS account using your account ID and password. CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS) using the establishment’s FURLS account ID and password. See Accessing CECATS and Creating a Subaccount for additional instructions on how to access the system or set up a subaccount.
  • Choose the application needed:
    • Certificate to Foreign Government
    • Certificate of Exportability under Section 801(e)(1)
    • Certificate of Exportability under Section 802
    • Non-Clinical Research Use Only Certificate
    • Export Permit Letters under Section 801(e)(2)
    • Simple Notifications under Section 802.

Detailed instructions for each application type are available while in CECATS by clicking on the question mark symbol on the page. Instructions can also be accessed on the CECATS Help Documentation webpage.

If you have any questions regarding using CECATS, please email cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3.
For more information about CECATS, please view the Exporting Medical Devices Frequently Asked Questions page.

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Paper Application or Notification

Effective October 1, 2016, upon receipt of a paper application or notification, requestors will be contacted to submit their request using CECATS.

Please contact CDRH Exports Team with questions at cdrhcecats@fda.hhs.gov or call 301-796-7400 and select option 3.

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Information required for export requests and notifications

Certificate to Foreign Government (CFG):

  • Registration or owner/operator number for all manufacturers involved with the design and manufacture of the devices, including but not limited to the specification developer, manufacturer, contract manufacturer, contract sterilizer, repackager, relabeler
  • Product code and marketing status for each device
  • Recalls occurring within the past 10 years
  • Product list
  • Return shipping label – FedEx Express or UPS, self-addressed.

Requestors applying for a CFG are required to sign an Exporter’s Certification Statement indicating that they comply with requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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

  • Registration or owner/operator number for all manufacturers involved with the design and manufacture of the devices including but not limited to the specification developer, manufacturer, contract manufacturer, contract sterilizer
  • Classification of each device
  • Product list
  • Return shipping label – FedEx Express or UPS, self-addressed.

Requestors applying for a COE 801 are required to sign an Exporter’s Certification Statement indicating that they meet the criteria of Section 801(e)(1) of the FD&C Act. False statements are violations of United States Code Title 18, Chapter 47, Section 1001.

Certificate of Exportability under Section 802 (COE 802):

  • Registration or owner/operator number for all manufacturers involved with the design and manufacture of the devices including but not limited to the specification developer, manufacturer, contract manufacturer, contract sterilizer
  • Classification of each device
  • Product list
  • Return shipping label – FedEx Express or UPS, self-addressed.

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

Non-Clinical Research Use Only Certificate:

  • Manufacturer information
  • Product list
  • Return shipping label – FedEx Express or UPS, self-addressed.

Export Permit Letter requests:

  • Manufacturer information
  • A complete description of the device intended for export
  • The status of the device in the U.S., such as whether is the device is banned or is for investigational use
  • A statement indicating that the requestor conducted a search of the National Library of Medicine (NLM) database (see instructions for searching the U.S. National Library of Medicine (NLM) databases below). The statement should include 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
  • 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.
  • Return shipping label – FedEx Express or UPS, self-addressed.

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 Institutional Review Board 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).

Simple Notification to the FDA for Exporting under Section 802:

  • The device's trade name;
  • The type of device;
  • The device's model number; and
  • The country that is to receive the exported device if the export is to a non-Tier 1 country.

If the export is intended for a listed Tier 1 country listed in Section 802(b)(1)(A)(i) and (ii) of the FD&C Act, then the notification may, but is not required to, identify the importing country. It may also state that export is to a Tier 1 country without identifying the listed country. Tier 1 countries are: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the European Union, or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association).

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Shipping Label

You are required to provide a prepaid FedEx Express or UPS self-addressed label for the FDA to mail your certificates or permit to you once they are printed. FEDEX Ground or FEDEX Home labels are not accepted. The label should be unique for each application and self-addressed to a U.S. location.

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