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Importing Medical Devices in Compliance With U.S. FDA
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

Presenters:
- 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

Aug 25, 2021 12:00 PM in Eastern Time (US and Canada)

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