Canada – New regulations strengthening the post-market surveillance and risk management of medical devices in Canada

Changes to the regulations

Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing post-market surveillance authorities. With these amendments, we have implemented certain powers included in Vanessa’s Law and additional measures to improve post-market surveillance of medical devices. Together these will help to reduce the risk of medical devices and improve their safety, quality and effectiveness.

The post-market surveillance regulations amending the Medical Devices Regulations will improve our ability to identify, assess and manage new risks for medical devices used in Canada…