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

– Jennifer Diaz
– Denise Calle

Who Should Attend:
– Importers
– Customs Brokers
– Regulatory Affairs Professionals
– In-house Legal Counsel
– Product Development Managers
– Consultants
– Others Interested in FDA

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