How to Register for a Device Foreign Exporter Number

Understanding the FDA Database

The FDA maintains an internal database for registration information of non-US firms, including foreign manufacturers and device exporters. To conduct business effectively, it is crucial that your DEV (Device Exporter) and DFE (Device Foreign Exporter) numbers match the FDA's database to pass validation. These numbers are critical for ACE (Automated Commercial Environment) usage, which ensures firm name and address match the registration number provided.

Registration Process for Exporters

Begin by registering with the appropriate licensing agency. Determine which federal department oversees your exports to know if a license is needed. For medical device exporters, registration with the U.S. Food and Drug Administration is essential due to export control requirements.

Obtaining Your Exporter Registration Number

To obtain an exporter registration number, register with the SNAP-R (System for Award Management Registration) online system, free of charge. This system is essential for submitting export or re-export license applications and is maintained by the Bureau of Industry and Security (BIS).

Handling LST Numbers

LST (Listing Number) is necessary for some medical device entries, but it is not publicly searchable. It can be obtained by contacting the official correspondent of the firm. Remember, the FDA will not confirm or provide LSTs to individuals not listed as the official correspondent on the firm's registration.

Transmitting DEV and DFE Numbers

When you transmit your DEV and DFE registration numbers, you improve the chances of a successful lookup in the FDA's database. This step is vital for smooth operations within ACE and for complying with FDA regulations.

Frequently Asked Questions

What is the purpose of the device foreign exporter registration number database?

The Foreign Exporter Registration Number database is a system for listing foreign establishments that export or offer for export devices to the United States, and for these establishments to identify all known U.S. importers of their devices.

Who must register in the device foreign exporter registration number database?

All foreign establishments exporting devices to the United States, including contract manufacturers and sterilizers of finished devices, must register in the Foreign Exporter Database.

Are there any fees associated with the device foreign exporter registration number database?

Yes, all establishments that are required to register must pay the annual registration user fee as required by FDASIA. The Medical Device Excise Tax is not part of this fee and is not enforced by FDA.

How often must passwords be updated in the device foreign exporter registration number database?

Passwords for both the Owner Operator (O/O) and Official Correspondent (OC) expire every 90 days, and the system will prompt users to create a new password.

When must proprietary names be reported in the device foreign exporter registration number database?

All proprietary names under which a device is marketed must be reported when a device is first listed and during the annual update of registration and listing information.

Common Use Cases

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  Streamlining the customs clearance process for imported devices
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  Enabling faster verification of foreign device manufacturers for compliance purposes
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  Facilitating international trade research by providing access to a database of device exporters
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  Enhancing market surveillance by tracking the distribution of devices from foreign exporters

Why Choose Sourcetable for Device Foreign Exporter Registration Number Database

Sourcetable streamlines data integration from multiple sources, offering an efficient solution for managing device foreign exporter registration numbers. Its ability to centralize data in a single spreadsheet-like interface simplifies the tracking and reporting process for businesses dealing with international device exports.

With real-time querying capabilities, Sourcetable ensures that users have up-to-date access to registration numbers, a critical feature for compliance in the rapidly evolving global market. It eliminates the lag between data entry and retrieval, making it a superior choice for businesses requiring immediate data manipulation and decision-making.

The intuitive spreadsheet-like interface of Sourcetable allows for seamless manipulation of registration data without the need for complex database software. This user-friendly approach democratizes data management, making it accessible to teams without specialized technical skills, enhancing productivity and reducing errors.