Following a first-of-its-kind investigation into serious patient injuries associated with use of implants, the Canadian Minster of Health called on Health Canada to issue a new action plan for medical devices.
“I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices,” said Minister of Health Ginette Petitpas Taylor. “Health Canada has been taking steps to strengthen its regulation of medical devices, and I have asked that this work be accelerated.”
The call for Health Canada to strengthen three areas in its regulation of medical devices comes after a investigation led by the International Consortium of Investigative Journalists offered a look into the extent of harm facing patients with surgically implanted medical devices.
Health Canada has already been working on its regulations under a five-year initiative aimed at improving reviews and patient access. Device-related efforts announced this year under the initiative include changes to post-market surveillance regulations, proposed in conjunction with the creation of a new premarket approach on digital health along with a new digital health division, as well as a pilot launched in September to provide a new framework to obtain early pre-submission advice.
Based on a review conducted under its Regulatory Review of Drugs and Devices initiative, Health Canada also proposed changes to its process for device companies to request priority reviews just last month.
But the Government of Canada believes more work can be done to strengthen oversight and provide greater transparency around Health Canada’s premarket approval process, especially for medical devices of higher-risk, said Taylor…