Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada
Major regulatory update introducing new regulations to strengthen post-market surveillance and risk management frameworks for medical devices. These regulations represent significant enhancements to Health Canada's monitoring capabilities for devices already in use.
📅 Effective / published: 2020-12-23
Manufacturers and sponsors placing medical devices on the Canada market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗