Dive into the dynamic world of medical device innovation with a focused examination of the US Breakthrough Device Designation pathway alongside China’s burgeoning medical device sector. This insightful overview unpacks the expedited regulatory processes in the US designed to facilitate the development of groundbreaking technologies and juxtaposes it with China’s rapid strides in medical innovation. Understanding these frameworks not only enhances market access but also drives advancements in patient care. This lecture is ideal for students who want to explore the pivotal role of regulatory strategies in shaping the future of healthcare innovation in two leading global markets.