Upcoming Changes
This page summarises regulatory developments that were in progress or anticipated as of May 2026. Always verify status against official Health Canada and Canada Gazette sources.
UDI implementation
Health Canada's UDI framework was anticipated to move from consultation to final regulations. Key expected features:
- IMDRF-aligned UDI structure (Device Identifier + Production Identifier)
- Phased implementation by device class (Class IV first, Class I last)
- MDALL database updates to include UDI data
- GS1 and HIBCC as accredited issuing agencies
What manufacturers should do now:
- If you have UDI for FDA or EU markets, your UDI will likely be accepted for Canada with minimal modification
- Engage with Health Canada's UDI working group if you have complex product lines
- See UDI Framework
Mandatory post-market surveillance requirements
Draft amendments to formalise post-market surveillance requirements for Class III and IV devices were anticipated, potentially requiring:
- Formal PMS plans submitted with Device Licence applications
- Mandatory PSUR submission at defined intervals
- Structured post-market clinical follow-up for novel Class IV devices
Digital health and SaMD regulations
Further regulatory guidance (and potentially regulatory amendments) on Software as a Medical Device, including:
- Predetermined change control plan requirements for adaptive AI/ML algorithms
- Cybersecurity minimum requirements for connected devices
- Regulatory framework for AI-assisted diagnostic devices
Upcoming changes listed here are anticipated based on Health Canada consultation documents and regulatory proposals. Timing and final content may differ. Always verify against official sources.