Health Canada Announces New Medical Device Directorate

Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently within the Marketed Health Products Directorate

“The landscape for medical devices is changing rapidly and innovation is challenging Health Canada and all its partners to increase our focus on medical devices,” said Pierre Sabourin, assistant deputy minister for the Health Products and Food Branch, in announcing the news to stakeholders.

The directorate will add capacity and focus on expanding Quality Management System and implementation of ISO 9001. It will also strengthen postmarket surveillance and will build on Health Canada’s newly created digital health unit.

Among other device-related changes, Health Canada says it is being challenged to:

• Shift how it regulates investigational trials;
• Re-examine risk-based approaches;
• Find ways to regulate software that allow for rapid innovation cycles; and
• Create new pathways for innovative technologies.

The MDD will have a staff of 165 and a budget of almost Can$16 million ($12 million).

The new directorate “will position Health Canada to be more focused on this evolving product line and more agile and adaptable to its rapid growth and change,” Sabourin said.

“Although Canada has one of the best regulatory systems in the world for medical devices with some of the most stringent requirements, the pace of change is challenging us to do better. Creating the MDD is a significant step in response to this challenge and set up the medical device program for a successful future,” the agency said.