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Medical Device Regulation in the U.S., China and the EU: Overview, Recent Developments, and Trends

Date: Friday, May 10, 2019 10:00 AM - 2:30 PM

Venue: Covington & Burling LLP, Frankfurt

On May 10, 2019, members of our Covington medical device practice, Kristin Davenport, John Balzano, Dr. Dr. Adem Koyuncu, and Christine Kuhn will be hosting a seminar in Frankfurt on device regulation in the United States, China, and the EU. This will be a four-hour multi-jurisdictional seminar with the following topics and room to discuss additional topics of interest to attendees:

  • Requirements for Marketing Devices in the U.S. and China: Premarket Review and Postmarket Requirements
  • Building on the EU CE-mark for access to the U.S. and China, including FDA's and the National Medical Products Administration's (i.e., China FDA's) Policies for Accepting Foreign Clinical Data
  • Recent Developments in U.S. and China Medical Device Regulation
  • The new EU Medical Device Regulation: Consequences for Device companies in and outside of the EU
  • Labeling and Promotional Considerations for Devices Marketed in the U.S., China, and the EU
  • Development and Marketing of Combination Products and Companion Diagnostics

To RSVP, please reach out to Katelyn Aumann.