25 June 2019
Canada Launches Consultations to Improve Medical Device Safety
Health Canada is seeking comments from interested parties by 26 August on a proposal intended to further ensure the safety and effectiveness of medical devices in Canada. Specifically, Health Canada is proposing to require medical device manufacturers to:
- if requested, assess the safety of their products and do further safety testing when issues are identified;
- if requested, provide an analysis of the safety and effectiveness of their products so that Health Canada could conduct a post-market safety review; and
- prepare annual summary reports of all known adverse effects, reported problems, incidents and risks, and notify Health Canada if there has been a change to the risks or benefits.
These proposed amendments would extend the provisions of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) to medical devices and require medical device holders to provide Health Canada with safety information about devices once they are on the market. Health Canada believes these provisions would help the agency better understand the risks and benefits of marketed medical devices, which would contribute to improving the safety of medical devices used by Canadians.