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Latest / Health and life sciences

PolicyHealthCanadaConfirmed

Health Canada consults on draft pre-market guidance for machine-learning devices

See how this story connects

Source: Health Canada

Health Canada opened consultation on 30 August 2023 on draft pre-market guidance for machine learning-enabled medical devices. The consultation closed on 29 October 2023. The draft sets out evidence of safety and effectiveness across a device’s lifecycle and proposes a pre-determined change control plan to pre-authorise planned changes.

Why it matters

Makers of machine-learning devices sold in Canada got a proposed route to pre-authorise planned model updates, matching the mechanism the FDA had proposed in April 2023.

When
30 Aug 2023
ID
WTA-N-2023-0166
Where
Canada
Who
Health Canada

Summary by wheresthe.ai, from Health Canada. Checked against the source on 9 Oct 2026.

Read the original at Health Canada

Source copy: download the page text as saved on 19 Oct 2026 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: What happened nextFDA, Health Canada and MHRA publish transparency principles for machine-learning devices

Cite this story

WTA-N-2023-0166: “Health Canada consults on draft pre-market guidance for machine-learning devices.” wheresthe.ai, 30 Aug 2023. https://wheresthe.ai/d/ca-health-canada-mlmd-draft-guidance-2023-08/ (source: Health Canada).

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