Minister of Health on the Regulation of Medical Devices in Canada.
Calling the reforms a “priority,” Minister Ginette Petitpas Taylor said she has directed Health Canada to bring forward a comprehensive action plan to better police problematic devices, more transparently report their risks to the public and improve how the regulator approves devices.
“I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices,” Minister Petitpas Taylor said in a statement. “The Government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities.”
The Star/CBC investigation was part of a global examination of the medical device industry and its overseers, led by the International Consortium of Investigative Journalists. Canada’s health minister joins a growing number of government officials, including ministers from Germany, Italy and Denmark who have vowed to review or overhaul how their countries regulate implantable devices.
Our investigation found medical devices — from a heart valve to an artificial hip — that had been pulled from the market in other countries because of health risks continued to be implanted into unsuspecting Canadians, sometimes with tragic results.
Meanwhile, some Canadians are never told their implants have been recalled or subject to safety warnings.
Health Canada will propose new rules requiring device makers to inform the regulator “promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly,” the minister said.