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U.S. Import Controls/Product-Specific: Medical Devices
For imports of medical devices, what is the role of a United States Agent for Foreign Manufacturers?
What is FDA's role in regulating imports of medical instruments?
What are FDA's overall requirements for importing medical devices?
Device Classification
What are "General" and "Special" Controls on imports of medical devices?
How does the Medical Device Provisions of FDA Modernization Act apply to imports of medical devices?
How does the Medical Device User Fee and Modernization Act (MDUFMA) apply to imports of medical devices?
What are the labeling requirements for imports of medical devices?
How does FDA's Bioresearch Monitoring Program apply to imports of drugs, biologics, medical devices, veterinary medicines, and food areas?
Do I need to obtain FDA Premarket Approval (PMA) for imports of medical devices?
Who can submit a Premarket Approval (PMA) for imports of medical devices?
Are data from foreign clinical studies accepted by FDA?
How does the sponsor notify FDA of a change in address of the official correspondent for the Premarket Approval (PMA) under review?
Is FDA approval required to change the trade name of a medical device?
Can the sponsor sell the Premarket Approval (PMA) to another company? How does the owner notify FDA of a change in ownership of a medical device?
Can the Premarket Approval (PMA) holder enter into a licensing agreement with another medical device manufacturer?
Can the sponsor change the manufacturing site of the Premarket Approval (PMA) approved medical device?
Does an extension of product shelf life of a medical device require a Premarket Approval (PMA) supplement?
How can I find more information about a Premarket Approval (PMA) for a medical device under review?
Can I obtain a copy of a Premarket Approval (PMA) submission for a medical device?
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