AdvaMed Hosts Korea Food and Drug Safety Ministry for International Discussion of Digital Health Technology Regulation 

AdvaMed Staff (Geeta, Tara and Jamie) listen intently to presentations from Director General Chae and Assistant Director Kim on developments in Korea’s digital health space. 

AdvaMed was privileged to host a delegation from Korea’s Ministry of Food and Drug Safety (MFDS) at our offices for an informative session on the regulation of digital health technology. In attendance from the Korean government were Gyuhan Chae, Director General, Medical Device Safety Bureau, and Byung-gwan Kim, Assistant Director, Medical Device Safety Bureau.   

Director General Chae gave an interesting presentation on Korea’s recently introduced legislation, the Digital Medical Product Act.  Cassie Scherer, Medtronic’s Senior Director of U.S. Regulatory and Global Digital Health Policy, gave a comprehensive presentation providing an overview of FDA’s regulation of digital health. Jason Gorman, VP of Quality, Regulatory and Compliance of Propeller Health, provided an interesting virtual overview of Propeller’s technology. 

Several members of the AdvaMed staff gave presentations as well.  The session was a good opportunity to exchange ideas, best practices and practical considerations relating to the regulation of the growing area of digital health.  

Learn more about AdvaMed’s global work.  

Fatemeh Razjouyan (Director, Regulatory Policy, International, and Harmonization, Medtronic), Cassie Scherer (Senior Director of U.S. Regulatory and Global Digital Health Policy, Medtronic); Jonathan Goldberg (Commerce/Office of Health Information Technologies); Matthew Hein (Commerce/ITA) and Joseph Gatewood (AdvaMed) listen intently to presentation from KMFDS. 

Participants wrap up a productive meeting with a memorable photo.  From the left to right, Jonathan Goldberg, International Trade Specialist, Office of Health Information Technologies, US Dept of Commerce; Joseph Gatewood, VP, Global Strategy, Richard Price, Senior VP, Payment and Tara Federici, VP, Technical and Regulatory (AdvaMed); Cassie Scherer, Senior Director of U.S. Regulatory and Global Digital Health Policy, Medtronic; Assistant Director Byung-gwan Kim, Medical Device Safety Bureau, KMFDS; Director General Gyuhan Chae, Medical Device Safety Bureau, KMFDS