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Medical masks and respirators: Information for manufacturers (Updated)

🇨🇦 Canada (Health Canada)📋 Regulatory Change

Updated guidance document for manufacturers regarding medical masks and respirators regulation and requirements in Canada. Reflects current regulatory expectations for these medical devices.

📅 Effective / published: 2025-06-26

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 ↗