Canada NewsWire
OTTAWA, June 14, 2019
New regulations would make it easier for Health Canada to take action to protect the health and safety of Canadians
OTTAWA, June 14, 2019 /CNW/ - 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:
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.
Quote
"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
Quick Facts:
Associated Links
Canada Gazette, Part 1, Consultation Document
Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality
SOURCE Health Canada
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