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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 codes from FDA or EU markets, you should verify compatibility with Canada's issuing agency requirements (GS1 or HIBCC); direct cross-acceptance has not been officially confirmed.
  • If or multi-jurisdiction UDI requirements, consider engaging through MEDEC (Medical Devices and Diagnostics Industry Association) or Health Canada's regulatory consultation channels for technical guidance. 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
caution

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.

Official source

Health Canada — Upcoming regulatory changes

Modify the bullet point to read: 'Regulatory framework for AI-assisted diagnostic devices (regulatory status—guidance vs. amendments—to be confirmed)'