Recent Regulatory Changes
Current to May 2026. Always verify against the Canada Gazette and Health Canada's official communications.
2025–2026
MDSAP audit requirements — ongoing enforcement
Health Canada continues to require a current MDSAP audit certificate (or equivalent) for all Class II–IV Device Licence applications and amendments. Certificates from all five MDSAP jurisdictions (Canada, USA, Australia, Brazil, Japan) are accepted. Health Canada has confirmed that ISO 13485 certificates alone are no longer sufficient for new Device Licence Class II–IV applications; however, ISO 13485 may still be acceptable as supplementary evidence for Class I devices.
Health Canada released further consultation documents on its proposed Unique Device Identification (UDI) framework, aligned with the IMDRF UDI framework. As of May 2026, final regulations remain under development with expected publication in the Canada Gazette, Part II in 2026–2027.
SaMD and AI/ML guidance update
Health Canada released updated guidance on Software as a Medical Device and AI/ML-based medical devices, incorporating IMDRF N23 guidance on SaMD clinical evaluation and new IMDRF guidance on predetermined change control plans for adaptive algorithms. Manufacturers of AI/ML SaMD should review their clinical evidence and PMS plans against the updated guidance.
Cybersecurity expectations for connected devices
Health Canada has reinforced expectations for cybersecurity documentation in Device Licence applications for connected devices, following publication of international guidance on medical device cybersecurity (IMDRF MDCE WG N60). A Software Bill of Materials (SBOM) is now expected in submissions for connected devices.
2023–2024
Post-market surveillance guidance update
Health Canada updated its guidance on post-market surveillance, aligning more closely with IMDRF guidance on PMS plans and PSURs. The updated guidance clarifies the expectation that Class III and IV device holders proactively monitor published literature and adverse event databases.
Bilingual labelling enforcement
Health Canada increased enforcement activity on bilingual labelling compliance, particularly for devices imported from non-bilingual markets. Foreign manufacturers entering the Canadian market should ensure bilingual (English and French) labelling is in place before the first import.
This page summarises key changes. For the complete regulatory change history, consult the Canada Gazette and Health Canada's guidance document revision history.
This page is updated quarterly to reflect published regulatory changes, consultation closures, and finalized guidance documents. Changes listed here are based on official Canada Gazette publications and Health Canada announcements. For intra-quarter updates, consult the Canada Gazette and Health Canada's What's New page directly.
See also: UDI Framework