Canada – Health Canada Creates New Medical Devices Directorate

In a letter to stakeholders late Thursday, Health Canada announced the creation of a new Medical Devices Directorate to better respond to the challenges and opportunities related to the growing medical device industry.

Similar to the US FDA’s push for a lifecycle approach to regulating devices, the new Canadian devices directorate will take a lifecycle approach by bringing together postmarket functions now led by the Marketed Health Products Directorate and the pre-market functions of the Therapeutic Products Directorate.

The directorate will include 165 positions and a budget of $15.85 million funded through resource transfers and reallocation within Canada’s Health Products and Food Branch. David Boudreau, executive director at Health Canada, was named the interim director general for the new device directorate…