All Medical devices imported into the United States are under the direct control of the Food and Drug Administration (FDA). No medical device can be imported into the country without FDA approval. Obtaining FDA approval to import a medical device into the United States is a long and tedious process.

For purposes of exhibitions such as FIME, there are several legal ways to bypass FDA approval.

The main thing to keep in mind is that no matter which legal method we employ to get your medical devices into the U.S., at the end of the exhibition the medical devices must be exported out of the country. The only exception are SAMPLES NOT FOR RESALE.

The legal methods to import medical devices into the United States without FDA approval are:

Use of a ATA carnet





Items under US$1.00, labelled as SAMPLES NOT FOR RESALE





Samples for Soliciting Orders





Temporary Importation Bond (TIB)

In order to clear the cargo through U.S. Customs we would need a copy of the cargo invoice and a copy of the Ocean Bill of Lading or the Air Waybill. In addition, in order to be able to act as your Customs Broker in the United States, our company must have a Power of Attorney completed by the Importer of Record. The Importer of Record is the company or individual acting as the importer for the cargo.

For non-medical devices, or for FDA approved medical devices, a Formal Entry must be made. The information required for for Formal entries is shown below as "None Required Medical" and "None required Non-Medical.

Please refer to the table below in order to determine the Importer of Record:

The SOLD TO in the cargo invoice and the consignee block of the Ocean Bill of Lading or the Air Waybill must be completed as follows:

Full payment must be received before cargo can be delivered to the Exhibition Hall.
Payment may be by Bank Wire or by Credit Card (VISA or MASTERCARD)