Health Canada launches consultations to improve the safety of medical devices
New regulations would make it easier for Health Canada to take action to protect the health and safety of Canadians
June 14, 2019 - Ottawa, Ontario - Health Canada
Medical devices are vital to the health and well-being of hundreds of thousands of Canadians, many of whom could not survive without them (e.g., insulin pumps, pacemakers). Canadians expect the medical devices they use to be safe and reliable.
Today, the Honourable Ginette Petitpas Taylor, Minister of Health, launched consultations that give Canadians an opportunity to comment on proposed changes to regulations that would further ensure the safety and effectiveness of the medical devices they use.
With these changes, manufacturers are required to:
- if requested, assess the safety of their products and do further safety testing when issues are identified;
- if requested, provide an analysis of the safety and effectiveness of their product so that Health Canada could conduct a post-market safety review; and
- prepare annual summary reports of all known adverse effects, reported problems, incidents, and risks; and notify Health Canada if there has been a change to the risks or benefits.
These new requirements would also help Health Canada better understand the risks and benefits of marketed medical devices, which would contribute to improving the safety of medical devices used by Canadians. Canadians can comment on the proposed regulations until August 26, 2019 by visiting the Canada Gazette website.
As part of its Action Plan on Medical Devices launched in December 2018, Health Canada committed to strengthening its monitoring and follow-up of medical devices already on the market. This regulatory proposal represents one key part of that plan.
“Canadians rely on medical devices to maintain and improve their health. Last fall, I committed to Canadians that we would take action to improve the safety of these devices. This consultation is an important part of that commitment. These proposed changes would make it easier for Health Canada to monitor the safety of medical devices already on the market and to take action to protect the health and safety of Canadians.”
The Honourable Ginette Petitpas Taylor
Minister of Health
These proposed amendments extend the provisions of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) to medical devices, and would require medical device holders to provide Health Canada with safety information about devices once they are on the market.
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduced amendments to the Food and Drugs Act that improve Health Canada's ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified.
Regulations introduced by Vanessa’s Law were published by Health Canada in 2017 and came into force in 2018 with respect to drugs. The current proposal would bring these same provisions into effect for medical devices.
Office of Ginette Petitpas Taylor
Minister of Health
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