Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices
Notice of proposed changes to Health Canada's guidance on recognized standards for medical device approval. Updates reflect evolving international standards and harmonization efforts.
📅 Effective / published: 2024-07-25
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 ↗