Life Sciences, Regulatory Focus News Letter

Health Canada Creates New Medical Devices Directorate

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.


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.

Health Canada said the new organization will allow for additional capacity and focus on expanding Quality Management Systems to include both internal and external components, and the implementation of ISO 9001. It will also enable better postmarket surveillance capacity for devices.
A new policy group within the directorate will help to develop new guidance tailored to medical devices, including more meaningful and targeted interactions with stakeholders, in addition to building on the expertise and activities of the newly created Digital Health Unit.

“Large-scale initiatives are underway that are challenging us to: shift how we regulate 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,” Health Canada said.

Last June, Health Canada began a consultation on a set of proposed regulations intended to provide the agency with better safety information for marketed Class II, III and IV medical devices. And last December, Health Canada created a medical device action plan to improve the safety, oversight and quality of devices.

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