Recent Amendments
Overview
The Medical Devices Regulations (SOR/98-282) have been amended periodically since coming into force in 1998. This page summarises significant recent and upcoming amendments. Always verify against the Canada Gazette and laws-lois.justice.gc.ca for the current authoritative text.
Recent significant amendments
MDSAP recognition
Health Canada amended the MDR to formally require MDSAP audit certificates (or equivalent) as part of Device Licence applications. This aligned Canada with the MDSAP framework shared with the US FDA, TGA (Australia), PMDA (Japan), and ANVISA (Brazil).
Mandatory problem reporting enhancements
Amendments to strengthen mandatory problem reporting requirements, clarifying what must be reported and tightening timeframes.
SaMD and AI guidance (ongoing)
Health Canada has been developing guidance (rather than regulatory amendments) on Software as a Medical Device and AI/ML-based devices, following IMDRF frameworks. Formal regulatory amendments for SaMD-specific requirements are anticipated.
UDI framework (anticipated)
Canada is developing a Unique Device Identification (UDI) framework aligned with IMDRF standards. A regulatory framework is anticipated, though final regulations were still in development as of May 2026. See UDI Framework.
Monitoring for changes
To stay informed of regulatory amendments:
- Subscribe to Canada Gazette email alerts for Part I (proposed) and Part II (final) entries tagged to the Food and Drugs Act
- Monitor Health Canada's medical devices consultation page for open consultations
- Subscribe to the RAPath CA What's New section for curated updates — What's New