Importing and Exporting Devices

Exporting Medical Devices

Export of Legally Marketed Devices

Requirements

Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. 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 a cleared Premarket Notification 510(k) or Premarket Approval (PMA) unless exempted by regulation or if the device was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act);
  • The device must meet the labeling requirements of 21 CFR Part 801and 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), unless exempted by regulation.

In addition, the U.S. exporter must comply with the laws of the importing country.

Please note that U.S. manufactures that export medical devices outside the U.S. are required to register their facility and list their devices (21 CFR 807).

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 Certificate for Foreign Government (CFG). These export certifications were formerly referred to as a Certificate for Products for Export or Certificate of Free Sale. The CFG is a self certification process that is used to speed the processing of requests. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal.

CDRH requires an initial fee of $175.00 per certificate and $15.00 per certificate for additional certificate(s) issued for the same product(s) in the same letter of request. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal.

You should submit your request for a CFG on form FDA-3613, Supplementary Information Certificate to Foreign Government Requests. Questions regarding the CFG should be directed to the Office of Compliance, Export Certificate Team, at 301-796-7400. (exportcert@cdrh.fda.gov)

Export of Unapproved Devices

Chapter VIII of the Federal Food, Drug, and Cosmetic Act (FD&C Act) addresses FDA regulation of the import and export of foods, drugs, cosmetics, biologics, medical devices, and radiation emitting electronic products. Sections 801 and 802 of Chapter VIII list the specific rules governing the import and export of products, including the export of unapproved products.

Until April 1996 the law that governed the export of medical devices not legally marketed in the U.S. was Sections 801(e)(1) and (e)(2) of the FD&C Act. Public Law 104-134, Food and Drug Export Reform and Enhancement Act of 1996 (FDERA) modified portions of Section 801 and Section 802. This law significantly modified Chapter VIII by enhancing the ability of U.S. firms to export unapproved FDA products under certain conditions without prior permission from FDA. The most notable change was the addition of provisions to and extension of section 802 to medical devices.

The basis for the regulation of imports and exports is contained in Chapter VIII of the FD&C Act. There are no regulations in the Code of Federal Regulations (CFR) that cover export requirements except for 21 CFR 812.18 regarding the export of investigational devices.

Section 803 provides for the establishment of an Office of International Relations to act as FDA liaison with foreign governments.

Please note that U.S. manufactures that export medical devices outside the U.S. are required to register their facility and list their devices (21 CFR 807).

 

Export Procedures for Unapproved Devices

Exporting Medical Devices Via Section 801(e)(1)

Requirements

A medical device which would be considered to be adulterated or misbranded,  may be exported under Section 801(e)(1) of the FD&C Act provided the device is intended solely for export. Although such a device would not meet the requirements of the FD&C Act to be sold domestically for commercial distribution, it may be exported legally and without FDA permission in accord with Section 801(e)(1) provided 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.

Once an adulterated or misbranded device is sold or offered for sale in commercial distribution in the U.S., it may not be exported under Section 801(e)(1) as an alternative to bringing the device into compliance with the requirements of the Act. Devices that have been imported are considered to be in domestic commerce.

Unapproved Devices due to lack of 510(k) marketing clearance

The FDA is aware that in certain instances there may be devices which firms may wish to manufacture solely for export, or which they may wish to export during the interim period while their Premarket Notification 510(k) is under review. FDA allows the export of a device that does not have a 510(k) marketing clearance without prior FDA clearance if it meets two conditions:

    • the device meets the requirements of 801(e)(1) listed above, and
    • it is reasonably believed that the device could obtain 510(k) marketing clearance in the U.S. if reviewed by FDA.

This includes only devices which are similar in design, construction, and intended use to class I or class II devices or which the firm reasonably believes would be “substantially equivalent” to class I or class II devices. Devices which would not be included under this consideration are:

    • Preenactment class III devices for which FDA has called for the submission of a PMA
    • Postenactment class III devices, i.e. placed on the market after May 28, 1976, or
    • Devices evaluated by a firm and found to be not substantially equivalent to a 510(k)’d device.

Recordkeeping Requirements

Persons exporting an article under section 801(e)(1) of the act or an article otherwise subject to section 801(e)(1) of the act must maintain records demonstrating that the product meets the requirements of section 801(e)(1) of the act. These records must 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 two years from the date of release for commercial distribution by the manufacturer (21 CFR 820.180). The records must be made available to the Food and Drug Administration (FDA), upon request, during an inspection for review and copying by FDA. The records required to be maintained under 21 CFR 1.101 include the following:

    1. Records demonstrating that the product meets the foreign purchaser’s specifications. The records must contain sufficient information to match the foreign purchaser’s specifications to a particular export;
    2. Records demonstrating that the product 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 product 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 18 U.S.C. 1001;
    3. Records demonstrating that the product is labeled 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 product does not have a shipping package or container, on shipping invoices or other documents accompanying the exported product; and
    4. Records demonstrating that the product is not sold or offered for sale in the United States: This may consist of production and shipping records for the exported product and promotional materials.

Certificate of Exportability

The FDA implemented a new certification process referred to as a Certificate of Exportability (COE) to facilitate export of a medical device under 801(e)(1). Exporters applying for a COE are required to sign a statement indicating that they meet the four criteria of 801(e)(1) as detailed above. False statements are violations of United States Code Title 18, Chapter 47, Section 1001. Penalties for a false statement include up to $250,000 in fines and up to five years imprisonment.

CDRH requires an initial fee of $175.00 per certificate and $15.00 per certificate for additional certificate(s) issued for the same product(s) in the same letter of request. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal. CDRH should to issue the certification within 20 days upon the firm’s showing that the product meets the applicable requirements.

You should submit your request for a COE on form FDA-3613a, Supplementary Information Certificate of Exportability Requests. Questions regarding the COE should be directed to the Office of Compliance, Export Certificate Team, at 301-796-7400. (exportcert@cdrh.fda.gov)

via Importing and Exporting Devices > Exporting Medical Devices.

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