In January 2025, Health Canada published a new guide on the use of recognized standards to demonstrate compliance with the requirements of the Medical Devices Regulations. The document guides manufacturers in preparing submissions, updates and lifecycle management of applicable standards.

Health Canada has begun automatically canceling MDEL licenses for operators who have not complied with the mandatory annual review. The measure affects distributors and importers of medical devices in Canada and has serious consequences, such as interruption of operations, the need to resubmit license applications, and product retention.