Canada Increases Surveillance Under Medical Device Action Plan
Canadian hospitals reported almost 3,500 medical device incidents to Health Canada in 2020, the agency said in a progress report on mandatory reporting requirements introduced as part of the agency’s Medical Device Action Plan.
Under the 2018 plan, Health Canada also issued new regulations on postmarket surveillance activities, giving the agency additional powers to request tests and studies from manufacturers in light of new information. Devicemakers are now required to notify the agency within 72 hours about serious risks related to their medical devices.
The mandatory reporting requirements “have been essential during the COVID-19 pandemic,” the agency said, noting that the information received from hospitals enabled the agency to assess risks more quickly.