Health Canada Releases Action Plan on Medical Devices

December 20, 2018 - Ottawa, ON - Health Canada

Canadians rely on medical devices, such as pacemakers and insulin pumps, to maintain and improve their health and well-being. Canada has one of the best regulatory systems in the world for medical devices, with some of the most stringent requirements. The Government of Canada is taking steps to further ensure the safety, effectiveness and quality of the medical devices used by Canadians.

Following the recent announcement by the Honourable Ginette Petitpas Taylor, Minister of Health, on medical devices, Health Canada has developed an Action Plan to accelerate its efforts to strengthen the regulation of medical devices in Canada.

This plan lays out a three-part strategy to deliver better health outcomes for Canadians who rely on medical devices for their health and well-being. The plan proposes actions to further improve how medical devices get on the market; strengthen monitoring and follow-up for devices already in use; and provide Canadians with more information about the medical devices they rely on. Under the plan, Health Canada will move quickly on a number of existing initiatives, including:

• publishing more information about decisions made on medical devices, by January 2019;
• increasing the number of inspections of foreign medical device manufacturers, by April 2019;
• advancing final regulations to require hospitals to report medical device incidents to Health Canada, by June 2019;
• proposing draft regulations that would require manufacturers to notify Health Canada within 72 hours if foreign regulatory agencies issue a warning about serious risks related to a medical device, by June 2019; and
• making clinical information and data about medical device incidents more easily available, by December 2019.

The plan also introduces new measures, including: 

• expanding Health Canada’s use of outside scientific expertise, including creating a new expert advisory committee on women’s health issues for drugs and medical devices, which will include patient participation and perspectives, by January 2019;
• introducing a proposal to allow healthcare professionals to conduct investigational testing of medical devices, by June 2019.

The Government of Canada’s priority is the health and safety of Canadians. Collaboration with provinces and territories as well as other health care partners will be fundamental to delivering results. Health Canada will strengthen and expand existing outreach and information activities, as appropriate, to reinforce these important partnerships. The Department will continue to ensure that medical devices in Canada meet the highest standards for safety, effectiveness and quality, and help Canadians make informed choices about their health and well-being.