About the Conference

The rules and procedures for the import and export of medical devices can be confusing and problematic, and are growing more so with new rules and with changes in international trade agreements.  Customs and FDA have been requesting more information and conducting more inspections and examinations than before.  Mistakes in procedures or documentation can lead to withheld or seized shipments and consequent financial lost to U.S. and foreign manufacturers, suppliers, and brokers.

This one-day program with speakers from government, industry, and consulting firms will cover the laws and regulations, recent changes, procedures, best practices, and common mistakes.


Topics will include:

  • The import process for medical technology
  • Databases, forms, and Affirmation of Compliance Codes
  • Roles and coordination of FDA and the Bureau of Customs & Border Protection
  • FDA actions and how to manage them
  • Import for Export
  • Export of legally marketed medical technology
  • Export of Un-approved and investigational medical technology
  • Case studies, watch-outs, and best practices


Who should attend:

  • Regulatory affairs
  • Global planning, marketing, & logistics
  • Sales managers
  • Brokers
  • Investors
  • Legal counsel
  • Supply chain managers

CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

  • When

  • Monday, April 15, 2019 - Tuesday, April 16, 2019
    11:30 AM - 12:00 PM

  • Where

  • Hogan Lovells
    555 13th Street NW
    Washington, DC 20004

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