Medical Device Regulation in China and the US: A Comparison and a Look Forward

Abstract

This paper explores the history and development of medical device regulation in both the United States and China. Through a detailed investigation of the path each country undertook to arrive at its current state of medical device regulation, it reveals the political and societal barriers each encountered and how these barriers forced regulation in the two countries to develop in two different ways. Due to situational and cultural circumstances, both countries have reacted to both domestic and international stimuli in some very similar and other vastly different ways. Strengths and weaknesses of the regulatory policies and agencies that have emerged in reaction to these stimuli are evaluated in hopes of revealing how much influence situational circumstances have upon a fundamentally identical technology. Ultimately, we formulate a critical understanding of what must be required for China's medical device industry to "catch-up" to international expectations.