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PRESENTERS: Jennifer Diaz, Denise Calle

CATEGORY: FDA 101

DATE: August 25, 2021 12:00 pm

This one-hour webinar provides an overview of FDA regulations and requirements for imports of medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device.

The presentation will cover the pathway to legally market a medical device in the US, including:

– How to determine if your product is a medical device
– How to find your “product code” and device class
– How to determine the requirements to import your device class into the U.S.
– How to register a medical device with the FDA
– Who needs a U.S. Agent
– How to perform due diligence on your manufacturer registration and listing information
– What premarket submissions are required for specific products
– Labeling requirements (including UDI) when importing medical devices
– “Top 10 Tips When Importing Medical Devices”
– Best practices for responding to enforcement actions

Who should attend:

– Importers
– Foreign Food Suppliers
– U.S. Food Importers
– Customs Brokers
– Regulatory Affairs Professionals
– In-house Legal Counsel
– Product Development Managers
– Consultants
– Others Interested in Trade


Eligible for 1 CCS/MCS NEI Credit
Input your NCBFAA NEI ID number at the time of registration to receive credit.