Health Canada on Friday launched a public consultation soliciting feedback on a set of proposed regulations intended to provide the agency with better safety information for marketed Class II, III and IV medical devices.
Specifically, the agency is proposing regulations that would amend the 2014 Protecting Canadians From Unsafe Drugs Act
, commonly known as Vanessa’s Law, to extend some of its provisions to medical devices.
Under the proposal, device makers would be required to provide annual summary reports of adverse events and to notify Health Canada if there have been any changes to a device’s benefits and risks.
The proposed regulations would also give the government authority to request safety assessments or order new safety testing for marketed devices, as well as to require device makers to provide analyses of the safety and effectiveness of their products to enable Health Canada to conduct postmarket safety reviews.
Additionally, the proposed regulations would strengthen reporting requirements for medical device safety issues that occur outside Canada. Under current regulations, device makers are required to report incidents that occur outside Canada only “if the regulatory agency of the country in which the incident occurred has required the manufacturer to take corrective action or if the manufacturer has indicated their intent to do so to the regulatory agency.”
Under the proposed regulations, device makers and importers would be required to report risks communicated outside Canada, changes to a device’s labeling in other countries, as well as recalls, reassessments and suspensions or revocations of licenses in other countries.
The proposed changes are part of the medical devices action plan
announced by Health Canada in December following an investigation
by the International Consortium of Investigative Journalists into patient harm linked to surgically implanted medical devices.
“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,” said Canada’s Minister of Health Ginette Petitpas Taylor.
, Canada Gazette