Canada’s Intellectual Property Firm

Health Canada intends to propose post-market amendments to the Medical Devices Regulations

On April 10, 2018, Health Canada issued a Notice of Intent to “propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada.” The intended amendments are to reflect changes made to the Food and Drugs Act (FDA) following the enactment of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). The proposed changes will, among other things, provide the Minister of Health with the authority to: (i) request analytical issue reports from a manufacturer when there is suspicion of a safety concern; (ii) require manufacturers to prepare annual reports and to notify Health Canada of any significant change in the safety of a medical device; (iii) compel manufacturers to conduct a reassessment and to require tests and studies; and (iv) require manufacturers to provide notification to Health Canada of any risk communications, changes to labelling, recalls, assessments, and suspensions, or revocations occurring in other countries. Health Canada intends to pre-publish the proposed regulatory amendments in 2019.