Know the fine points of export certificates and how to request them from expert Angela Bazigos in this 90-minute session.

1. Export Certificates for Medical Devices
Presenter
Angela Bazigos
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Successfully Export your Medical Devices

2. Contents
 Purpose
 Definitions
 Background
 What Certificate Do You Need?
 How to Request a Certificate
 Record Keeping
 Frequently Asked Questions (FAQ)
 References
 Q & A
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3. Purpose
 The purpose of the presentation is to
review the export certification process for
medical devices, describe what
“certificates” are, and the types of export
certificates, export permit letters & simple
notifications that a manufacturer/
distributor may request.
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4. Definitions
 An Export Certificate is a document prepared by FDA
that has information about a product’s regulatory or
marketing status in the U.S.
 The "Certificate to Foreign Government" is for the export
of human drugs and biologics, animal drugs, and
devices that can be legally marketed in the United
States. (CBER, CDRH, and CVM)
 The "Certificate of Exportability" is for the export of
human drugs and biologics, animal drugs, and devices
that cannot be legally marketed in the United States, but
meet the requirements of sections 801(e) or 802 of the
Act and may be legally exported. (CBER, CDRH, and
CVM)
 CDRH is the FDA Center for Devices & Radiological
Health, regulating Medical Device exports.
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5. To see the complete presentation check the
below link:
http://www.audioeducator.com/pharma-biotech/export-certificates-for-
medical-devices-07-31-14.html