Today we announced the addition of Health Canada SOR/98-282 and the agency’s latest Machine Learning-Enabled Medical Device (MLMD) guidance to its regulatory automation engine. This strategic expansion allows medical device manufacturers and consultants to proactively address compliance requirements for both traditional and AI/ML-based devices in Canada—before submission, audit, or inspection.
The integration of SOR/98-282, Canada’s Medical Devices Regulations, and the Health Canada MLMD guidance aligns with our mission to make global regulatory frameworks machine-readable, searchable, and automatically actionable. With this new support, companies can insure compliance against Canadian requirements, including emerging expectations for adaptive AI systems.
With Health Canada’s growing focus on Good Machine Learning Practices (GMLP), explainability, algorithm change protocols, and continuous learning controls, the MLMD guidance introduces a new layer of complexity for software-based medical technologies. this simplifies staying compliant—so that teams can confidently align their AI product documentation to both general SOR/98-282 standards and ML-specific considerations.
Users can now:
- Check compliance against SOR/98-282 and MLMD guidance in minutes
- Map gaps to relevant sections of the Medical Devices Regulations and associated guidance documents
- Ensure readiness for audits or licensing with Health Canada
- Collaborate with consultants and regulatory teams to resolve flagged issues before submission or audits
Health Canada is among the first global regulators to issue tailored guidance for AI and ML in healthcare, signaling a shift toward more structured and proactive oversight. This platform enables companies to meet these evolving standards without relying on time-intensive manual audits or fragmented documentation reviews.
This release also strengthens our value to its global network of QA/RA consultants, who can now accelerate Canadian market access for clients while reducing regulatory risk.
SOR was updated last December, so ensure that you are compliant to it!