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.
Certificates to Foreign Governments are the most frequently requested type of export certificate, but export certificates 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)
In November 2012 and March 2013, CDRH launched the first two phases of its CDRH Export Certification and Tracking System (CECATS). CECATS is a new voluntary electronic system that allows manufacturers and initial importers to request export documents online as an alternative to paper submissions. CECATS 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. During the first phase of the CECATS launch, the system was only available for Certificates to Foreign Governments requests. In March 2013, the second phase of CECATS was launched, making it available for the voluntary submission of requests for certificates of exportability under sections 801(e)(1) and 802 of the FD&C Act.
In February 2014, CDRH made a series of enhancements to CECATS that responded to user feedback.
CDRH expects to expand the capabilities of CECATS in early 2015 to accommodate the electronic submission of requests related to export permit letters, simple notification, and non-clinical research-use-only certificates. Until that time, manufacturers must still use regular mail for these requests.
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.
CDRH will hold online training sessions about CECATS via Adobe Connect on February 25th and March 25th 2014from 1:30 - 3:00 p.m. (EST). Advanced registration is not necessary, but we encourage participants to test their connection prior to the webinar. Participants will not be able to enter the meeting until the host has logged in on the day of the event.
For more information about CECATS, please view the Exporting Medical Devices Frequently Asked Questions page.
- Exporting Medical Devices Frequently Asked Questions
- Letter to Medical Device Establishments: Enhancements to CDRH Export Certification and Tracking System (CECATS)
- FDA Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996.
- CDRH Foreign Liaison List
- Guidance for Industry: FDA Export Certificates
- Exporting Products Regulated by Other Centers at the FDA
Compliance Policy Guides
- Certification for Exports, Compliance Policy Guide, Section 110.100 (CPG 7150.01)
- Export of FDA Regulated Products from U. S. Foreign Trade Zones, Compliance Policy Guide, Section 110.200 (CPG 7150.11)
Regulations and Law
- Regulations 21 CFR 1, Subpart E--Imports and Exports, §1.101 - Notification and recordkeeping
- Federal Register, "Exports: Notification and Recordkeeping Requirements," December 19, 2001 [PDF]
- FD&C Act, Chapter VIII - Imports and Exports