Despite being a relatively small jurisdiction, Canada’s Medical Device Directorate (MDD) plays a dynamic role in shaping global regulations and taking a leadership role in regulatory harmonisation and convergence. From close collaborations with the US FDA to consortiums with major regulators from Brazil to Australia, the MDD works hard to ensure no interruption to health product supply and provides support for innovation and trust building with patients. Health Canada has a culture of inclusiveness, dialogue, pragmatism and global vision which are necessary values in today’s ever more stringent regulatory environment. This article introduces the regulatory framework for medical devices and discusses some key initiatives undertaken by Health Canada.