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Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices

🇨🇦 Canada (Health Canada)📋 Regulatory Change

Notice regarding amendments to Medical Devices Regulations specifically addressing the continued importation and sale of COVID-19 medical devices in Canada. These amendments support ongoing regulatory flexibility for COVID-19 related medical device availability.

📅 Effective / published: 2023-02-22

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 ↗