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  1. Importing and Exporting Devices

Exporting Medical Devices

The rules that companies must follow when exporting medical devices depend on whether or not their devices have been approved or cleared by the Food and Drug Administration.

Medical devices that are legally marketed in the U.S. may be exported to anywhere in the world without prior FDA notification or approval. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the Federal Food, Drug and Cosmetic (FD&C) Act.

Depending on which section of the FD&C Act a firm is exporting under, it may need to request an export permit letter or export certificate, or it may need to submit a simple notification. This webpage contains information on exporting legally marketed and unapproved devices, with detailed instructions for obtaining export certificates and permits, as well as submitting simple notifications.

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products’ status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product’s regulatory or marketing status in the U.S.

A Certificate to Foreign Government is the most frequently requested type of export certificate, but a Certificate of Exportability may also be requested when exporting devices under sections 801(e)(1) and 802 of the FD&C Act or when exporting Non-Clinical Research-Use-Only devices.

Please note that, in order to obtain a certificate, the product must be exported from the U.S.

CDRH Export Certification and Tracking System (CECATS)

CECATS is a voluntary electronic system that allows manufacturers and initial importers to request export documents online as an alternative to paper submissions. The system offers several benefits, including a reduction in certificate processing time, savings on material and mailing costs for paper applications, real-time validation of firm-specific data, and status updates of the request.

Requests that can be submitted through CECATS, include:

CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS). Firms must have a FURLS account ID and password to access this system. Consult the “New User” section of the FURLS website for instructions on setting up an account.

For more information about CECATS, please view the Exporting Medical Devices Frequently Asked Questions page.

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