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Regulatory FAQ Database
Export Start-Up Kit
Trade Information Database
U.S. Export Controls/Product-Specific: Medical Devices
Which U.S. Government agency regulates exports of medical devices?
What are overall FDA requirements for exporting medical devices?
Do medical device exports require prior FDA notification or approval?
How can I determine if my medical device for export requires prior FDA notification or approval?
What are the FDA requirements for exporting an unapproved device?
What are the procedures for exporting an unapproved device?
What are the FDA requirements for exporting unapproved medical devices for investigational use?
How can I obtain an export certificate for medical devices?
What is Establishment Registration for medical device exports?
Who must pay an Establishment Registration Fee for medical device exports?
How are establisment activities defined for medical device exports?
Who must register as an establishment for medical device exports?
When should I register as an establishment for medical device exports?
Why are medicines and medical devices ineligible for Cuban Democracy Act (CDA) program for Cuba?
If a foreign government requires an export certificate for a medical device, how do I get one?
What requirements apply to traveling with medications and medical devices, such as needles or oxygen tanks?
What does FDA mean, when it attests to compliance with current Good Manufacturing Practice (cGMP) regulations in an Export Certificate?
What are the legal requirements for exporting unapproved products under sections 801(e) and 802 of the Act?
What are FDA's cGMP requirements for medical devices?
Where do I get more information on Export Certification processing for Medical Devices?
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