Types of Export Certificates

Overview

The Export Reform and Enhancement Act of 1996 authorized the Food and Drug Administration (FDA) to issue an export certificate that certifies in writing that the exported device, including radiation emitting electronic products that are medical devices, meets certain specified requirements. The Center for Devices and Radiological Health (CDRH) is responsible for issuing those certificates for medical devices. There are four types of certificates, which are issued based on the marketing status of the device:

Certificate to Foreign Government
Certificate of Exportability 801(e)(1)
Certificate of Exportability 802
Non-Clinical Research Use Only Certificate

An establishment may request a certificate from CDRH by submission of an application, and is required to pay a fee if the certificate is issued within 20 working days of receipt of the request for certification. Criteria for each type of certificate is described below.

Certificate to Foreign Government (CFG)

A Certificate to Foreign Government (CFG) is, for the export of medical devices that can be legally marketed in the United States (U.S.) that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Any medical device that is legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval.

U.S. establishments may request a CFG for any medical device that may be legally marketed in the U.S. A device may be legally marketed in the U.S. if the following requirements are met:

• The establishment must be registered with the FDA;
• The device must be listed with the FDA;
• The device must have a cleared Premarket Notification [(510(k)] , an approved Premarket Approval (PMA) Application (unless exempted by regulation), is a device that was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act), or was granted a De Novo classification;
• The device must meet the labeling requirements of Title 21 Code of Federal Regulations (CFR) Part 801 (21 CFR 801) or 21 CFR 809, if applicable;
• The device must be manufactured in accordance with the Quality System (QS) regulation of 21 CFR 820, unless exempted by regulation.

By completing the required application, an establishment certifies that:

• The establishment is registered with the FDA;
• The device is listed with FDA;
• Each device may be legally marketed in the U.S.;
• Each device is not the subject of an open recall;
• All facilities involved in the manufacturing process are in compliance with FDA’s applicable regulations; and
• Each device is being exported from the U.S.

A CFG may be requested by following the steps outlined in “How to Request Export Certificates or Permits and How to Submit Simple Notifications”.

Certificate of Exportability under Section 801(e)(1) of the FD&C Act (COE 801)

A Certificate of Exportability (COE) under Section 801(e)(1) of the FD&C Act (COE 801) is for the export of medical devices that may not be legally marketed in the U.S. and that meet the requirements of Section 801(e)(1) of the FD&C Act.

Medical devices that are not FDA approved, cleared, or have not had a De Novo request granted for marketing in the U.S. or that are exempt from pre-market notification requirements and not authorized to be legally marketed in the U.S., can be exported under Section 801(e)(1) of the FD&C Act, provided that they are intended for export only and meet the requirements of Section 801(e)(1) of the FD&C Act. Although such devices do not meet the requirements of the FD&C Act to be marketed in the U.S., they can be exported legally and without FDA permission per Section 801(e)(1) of the FD&C Act if they are class I devices or class II devices and they are:

• In accordance with the specifications of the foreign purchaser;
• Not in conflict with the laws of the country to which they are intended for export;
• Labeled on the outside of the shipping package that they are intended for export; and
• Not sold or offered for sale in the U.S.

The FDA is aware that there may be certain devices that firms wish to export while applications for clearance under Section 510(k) of the FD&C Act are under FDA review. As indicated in FDA’s guidance document, Exports Under the FDA Export Reform and Enhancement Act of 1996, a device may be exported without 510(k) marketing clearance if it meets two conditions:

• The device meets the requirements of Section 801(e)(1); and
• There is reasonable expectation that the device could obtain 510(k) marketing clearance in the U.S. if reviewed by the FDA because it is similar in design, construction, and intended use to an already approved or cleared device.

Establishments requesting a COE 801 are required to register and list their device. A device that is sold or offered for sale in the U.S. and is then found to be adulterated or misbranded cannot be exported under section 801(e)(1) of the FD&C Act as an alternative to bringing the device into compliance with the requirements of the FD&C Act. This also applies to devices that have been imported to the U.S. and are later found to be adulterated or misbranded.

Exporters applying for a COE 801 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.

A COE under Section 801(e)(1) of the FD&C Act may be requested by following the steps outlined in “How to Request Export Certificates or Permits and How to Submit Simple Notifications”.

Certificate of Exportability under Section 802 of the FD&C Act (COE 802)

A Certificate of Exportability (COE) under Section 802 (COE 802) may be issued, upon request, for the export of medical devices that may not be legally marketed in the U.S. and that meet the requirements of Section 802 of the FD&C Act. Unapproved Class III devices and Class II devices that are required to meet performance standards under section 514 of the FD&C Act can be exported under Section 802 of the FD&C Act if the establishments and the devices meet certain criteria. These include investigational devices, unapproved devices that did not obtain PMA approval (or for which a PMA has not been approved), and banned devices.

To obtain a COE 802, devices must be class II or class III and meet the requirements under Section 801(e)(1) of the FD&C Act. Specifically, the devices must:

• Be in accordance with the specifications of the foreign purchaser;
• Be labeled as intended for export on the outside of the shipping package;
• Not conflict with the laws of the country to which they are intended for export; and
• Not be sold or offered for sale in the U.S.

The requestor must certify that these requirements have been met.

The devices must also comply with Section 802(f) of the FD&C Act. Specifically, the devices must:

• Be in substantial conformance with the Quality System regulation or meet an international quality standard recognized by the FDA;
• Not be adulterated, other than by the lack of U.S. marketing approval, clearance, or granting of a De Novo classification request;
• Not be the subject of a notice by the Department of Health and Human Services that re-importation would pose an imminent hazard, nor pose an imminent hazard to the receiving country; and
• Not be mislabeled (in this case, labeling with the language, units of measure, or any other labeling authorized by the recipient country is permitted).

In addition, the device must comply with the laws of the receiving country and have valid marketing authorization by the appropriate authority in Tier 1 country as enumerated in Section 802(b)(1)(A)(i) and (ii) of the FD&C Act. 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).

There are additional situations where Section 802 of the FD&C Act applies. These include:

• Devices exported for investigational use – Medical devices may be exported under an Investigational Device Exemption (IDE). As per section 802(c), the export of a medical device for investigational use in any Tier 1 country may proceed in accordance with the laws of that country and is exempt from regulation under the IDE statutory requirements of Section 520(g) of the FD&C Act. The exporter may apply for a COE under Section 802 of the FD&C Act. Additional guidance can be found in Import and Export Of Investigational Devices as well as in Section 802 of the FD&C Act.
• Exported devices intended for further processing – As per section 802(d) of the FD&C Act, a medical device intended for further processing pending expected marketing authorization from a Tier 1 country may be exported for use in that country. Upon receipt of marketing authorization, the exporter may apply for a COE under Section 802 of the FD&C Act or may submit a Simple Notification to FDA once it begins to export the device under Section 802(b)(1)(A) of the FD&C Act. Additional information can be found in the guidance document Exports Under the FDA Export Reform and Enhancement Act of 1996.
• Devices intended for treatment of diseases not prevalent in the U.S. – As per Section 802(e)(1) of the FD&C Act, a medical device intended for the diagnosis, treatment, or prevention of a tropical or other type of disease not prevalent in the U.S., which does not otherwise meet the criteria of section 802 of the FD&C Act, may be exported with an FDA approved application for export if the FDA finds that:
  • The device does not expose patients to an unreasonable risk of illness or injury;
  • The benefits outweigh the risks of illness or injury from its use; and
  • The probable risks and benefits of using available device alternatives were considered.

A COE under Section 802 of the FD&C Act may be requested by following the steps outlined in “How to Request Export Certificates or Permits and How to Submit Simple Notifications”.

Non-Clinical Research Use Only (NCR) Certificate

The Non-Clinical Research Use Only (NCR) 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 U.S. under the FD&C Act.

An NCR may be requested by following the steps outlined in, “How to Request Export Certificates or Permits and How to Submit Simple Notifications”.