Key Regulatory Aspects and the Importance of Consensus Standards in Bringing Devices to Market

Abstract

Software and hardware innovations, smart devices, digitization in healthcare, IoT (Internet of Things), and other emerging device technologies are driving the medical device industry as one of the fastest growing markets around the globe. Medical devices carry some measure of risk that can potentially cause problems or result in harm impacting patient safety significantly. The challenge manufacturers face is obtaining government marketing authorization for the proposed new medical device before it can be legally sold in its respective jurisdiction. This chapter examines key regulatory aspects and the importance of the use of standards and their increasing importance as a regulatory tool in medical device regulation. Five countries or regions with advanced medical device regulatory systems were explored: the USA, European Union (EU), Canada, Australia, and Japan.