ABSTRACT
Historically, the role of the regulatory affairs function within companies that develop and sell medical devices has been more tactical than strategic. While this tactical focus has served the industry well in the past, regulatory authorities around the world are raising the bar for market access. Regulatory reforms as well as the increased availability of real-world safety and efficacy data continue to alter the path to approval and the underlying investment case for medical devices. Globalization will also play a key role in shifting regulatory requirements — New regulatory frameworks are evolving and regional partnerships will be the main driver of harmonization going forward, especially in the Asia-Pacific market area.
