Share your views: Draft Pre-market guidance for machine learning-enabled medical devices

From Health Canada

Current status: Closed

Opened on August 30, 2023, and will close to new input on October 29, 2023.

With the increase in artificial intelligence and machine learning in medical devices, Health Canada has developed the Draft Pre-market guidance for machine learning-enabled medical devices. This guidance:

Join in: how to participate

Send an email to with your ideas or comments to make yourself heard.

Who is the focus of this consultation

We seek to engage with medical device stakeholders, including:

Key questions for discussion

Health Canada invites you to provide feedback on the overall clarity and content of the draft guidance.

We also would like you to answer the following questions:

Health Canada will use the comments we receive to finalize the guidance document. Your feedback will help us clarify the factors that applicants should consider to demonstrate that the device is safe, effective and of high quality throughout its lifecycle.

Related information

Contact us

Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa ON K1A 0K9


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