Health Canada Guidelines for Software As A Medical Device

As part of Health Canada’s risk-based approach to ensure its transparency efforts are focused on Canada’s most important health concerns, including those related to COVID-19, the Department has updated its approach to posting medical device recalls online. As of June 22, 2020, Type III medical device recalls are no longer being posted on Health Canada’s Recalls and Safety Alerts Webpage. This web page can be accessed at

Based on the risk evaluation, companies are required to assign a health hazard classification (which are Type I, II and III) for the recall:

Type I: A situation in which there is a reasonable probability that the use of (or exposure to) a recalled device will cause serious adverse health consequences or death.

Type II: A situation where the use of (or exposure to) a recalled device may cause temporary adverse health consequences, or where there is not a significant probability of serious adverse health consequences.

Type III: A situation where the use of (or exposure to) a recalled device is not likely to cause any adverse health consequences.

Please note that Health Canada will continue to post Type I and II recalls. This is only a change to Health Canada’s online posting procedure. There is no change to the recall requirements under the Medical Devices Regulations (MDR). Where applicable, Medical Device Establishment Licence (MDEL) and Medical Device Licence (MDL) holders must still carry out Type III recall actions as required by the MDR. Health Canada will continue to track and review Type III recall reports and take any additional compliance and enforcement action as necessary.

Contact Us