In order to import medical devices subject to Premarket Approval (PMA) into the U.S., the device must have FDA approval through the PMA process as well as meet all applicable FDA regulatory requirements. At this time, FDA does not recognize regulatory approvals from other countries. Exporting Medical Devices provides a summary of FDA requirements for foreign manufacturers and importers of medical devices and products that emit radiation.
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. For a device to be legally in commercial distribution in the U.S., the following requirements must be met:
The manufacturing facility must be registered with FDA;
The device must be listed with FDA;
The device must have an approved Premarket Approval (PMA) application;
The device must meet the labeling requirements of 21 CFR Part 801 and 21 CFR 809, if applicable;
The device must be manufactured in accordance with the Quality Systems (QS) Regulation of 21 CFR Part 820 (also known as Good Manufacturing Practices or GMP).
Certificates for Foreign Government
While FDA does not place any restrictions on the export of these devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificates for Foreign Government (CFG). These export certifications were formerly referred to as Certificates for Products for Export or Certificates of Free Sale. The CFG is a self certification process that is used to speed the processing of requests. To obtain instructions on how to obtain a CFG, call 240-276-0132. (exportcert@cdrh.fda.gov) If you are unable to reach a person on the Export Certificate Team, please call 240-276-0130.
Export of unapproved devices must meet the requirements under sections 801 or 802 of the FD&C Act. The provisions for unapproved PMA devices are discussed below.
Exporting PMA Devices under Section 802
Requirements
Unapproved Class III devices may be exported under section 802 if the firm and the device meet certain criteria. These devices include unapproved devices which would not be able to obtain a PMA or whose PMA has not been approved. In order to qualify for export under 802, devices must meet the four requirements of 801(e)(1) and pass the restrictions set forth in 802(f). That is, the devices must:
meet the requirements of section 801(e)(1), that is, the device is
in accordance with the specifications of the foreign purchaser;
not in conflict with the laws of the country to which it is intended for export;
labeled on the outside of the shipping package that it is intended for export; and
not sold or offered for sale in domestic commerce.
substantially meet Quality Systems Regulation (also known as Good Manufacturing Practices) or an international quality standard recognized by FDA (currently, none are recognized),
not be adulterated other than by the lack of marketing approval,
not be the subject of a notice by 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 other than by possessing the language, units of measure, or any other labeling authorized by the recipient country. In addition, the labeling must comply with the requirements and conditions of use in the listed country which gave marketing authorization, and must be promoted in accordance with its labeling.
In addition to the requirements above, the device must comply with the laws of the receiving country and have valid marketing authorization by the appropriate authority in a listed (Tier 1) country. This means that a firm whose device has received marketing authorization in any of the Tier 1 countries can export that device to any country in the world as long as the device meets applicable requirements of the FD&C Act .
The exporter must submit a "Simple Notification " as per section 802(g) to FDA when the firm begins to export. No approval from FDA is required.
If the firm or device does not comply with the above criteria, the device cannot be exported under section 802. However, the device may qualify for exportation under section 801(e)(2).
Recordkeeping Requirements
Any person exporting a product under any provision of section 802 must maintain records [section 802(g)] of all devices exported and the countries to which the products were exported. In addition to the requirements in 801(e)(1) noted above, such records include, but are not limited to, the following:
The product's trade name;
The type of device;
The product's model number;
The consignee's name and address; and
The date on which the product was exported and the quantity of product exported.
These records must be kept at the site from which the products 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. That is, all records must be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer (21 CFR 820.180). The records shall be made available to FDA, upon request, during an inspection for review and copying by FDA.
Certificate of Exportability
Even though FDA does not require a firm to obtain written permission prior to export, a foreign purchaser may request proof of compliance with U.S. law prior to export. FDA will provide a Certificate of Exportability to the exporter under section 802 (COE) to facilitate export of a medical device under section 802.
Additional Information
Exporting Medical Devices provides a list of Tier 1 countries and additional information on simple notifications and Certificates of Exportability.
Exporting Unapproved PMA Devices Under Section 801(e)(2)
Requirements
Unapproved devices which would not be able to obtain a PMA, or whose PMA has not been approved, that do not meet the criteria under section 802 may qualify for export under section 801(e)(2). Export under section 801(e)(2) is required when exporting an unapproved Class III device in which:
the importing country will not accept the marketing authorization of a listed (Tier 1) country as described in Section 802; or
the device is not manufactured in substantial conformance with the Quality System (GMPs).
The device must meet the following criteria to be exported:
The device must meet the requirements under Section 801(e)(1) of the FD&C Act, that is, the device is;
in accordance with the specifications of the foreign purchaser;
not in conflict with the laws of the country to which it is intended for export;
labeled on the outside of the shipping package that it is intended for export; and
not sold or offered for sale in domestic commerce.
A review by FDA must determine that the exportation of the device is not contrary to public health and safety and;
The device has the approval of the country to which it is intended for export.
Export Permit
To obtain FDA's approval to export these devices in accord with Section 801(e)(2) of the FD&C Act, a request that includes the following information must be submitted to FDA:
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, unapproved PMA product, etc.; 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:
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.
a statement that the requestor conducted a search of the Medlars database and a summary of the search results, and a summary of safety data to demonstrate that export of the device will not be contrary to the public health and safety.
A notarized certification from a responsible company official in the United States may be provided as an alternative to a letter from the foreign government [Section 1.101(b)(2)]. The letter should state:
the product is not in conflict with the foreign country’s laws.
the certification must include a statement acknowledging that the responsible company official is making the certification is subject to the provisions of 18 U.S.C 1001. This statutory provision makes it a criminal offense to knowingly and willfully make a false or fraudulent statement, or make or use a false document, in any matter within the jurisdiction of a department or agency of the United States. This statutory provision also makes it a criminal offense to knowingly and willfully fasify, conceal, or cover up by any trick, scheme, or device, a material fact in any matter within the jurisdiction of a department or agency of the United States.
If the manufacturer is exporting to a country within the European Economic Area (EEA) a device that has been awarded the "CE mark," FDA will accept documentation of the "CE mark" in lieu of a letter from the foreign government or responsible company official approving importation.
Additional information
Exporting Medical Devices provides additional information on requirements and instructions on how to obtain an export permit under 801(e)(2).
