Canada – Health Canada responds to COVID-19 emergency

Health Canada (HC) has issued a series of announcements of emergency measures and guidance documents since COVID-19 was declared to be a global pandemic. The agency’s actions that will most directly impact medical device manufacturers (and manufacturers outside the industry who are temporarily producing medical supplies) are detailed below. HC has also published an online COVID-19 resource centerone section of which gathers information for manufacturers and distributors of PPE, medical devices, and IVDs.

Mandatory reporting requirements remain in place during the COVID-19 pandemic

HC issued a notice clarifying expectations regarding mandatory reporting of adverse reactions and incidents during the pandemic. This stated that requirements are still applicable and that the timeline for reporting should be maintained as closely as possible, but that the government body recognizes the potential for unavoidable delays. If such delays occur, medical device manufacturers and responsible parties should report events as soon as possible and document what has been delayed. Incidents associated with COVID-19 should be reported according to the first Interim Order listed below