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Health Canada to Release Action Plan for Medical Devices Amid Reports of Faulty Implants

Posted 04 December 2018 | By Ana Mulero 

Health Canada to Release Action Plan for Medical Devices Amid Reports of Faulty Implants

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.

The three identified areas Health Canada will seek to address via the action plan involve improving premarket approval processes, industry reporting of adverse events associated with device use and access to clinical data used as part of premarket applications in support of an approval.

New activities in the area of premarket approvals relate to expanding on the use of outside experts to advise on medical device issues and enabling more research conducted by health professionals.

For enhanced post-market surveillance, Health Canada will seek to begin making medical device incident reports publicly available, propose to require companies to report their receipt of a device-related warning from foreign regulators and increase its capacity to conduct manufacturing site inspections with the goal of identifying issues before they may impact patients. These commitments expand on the modifications to post-market surveillance regulations Health Canada proposed in April.

Health Canada also pledged to provide additional information to aid Canadians in making “better informed decisions about their use of medical devices,” generating summaries of decisions for approved Class III and Class IV devices, and improving providers’ access to clinical data used for premarket approvals, Taylor added.

The regulatory authority intends to release its new action plan for medical devices in the coming weeks.


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