Consultation on Draft Guidance Document for Software as a Medical Device (SaMD)

From: Health Canada

Current status: Open

This consultation will be open until March 29, 2019.


Health Canada has developed a Draft Guidance Document for Software as a Medical Device (SaMD) to better define the regulatory compliance requirements for emerging technologies. We are seeking input from stakeholders regarding the criteria and interpretations put forth to regulate software products in Canada. Specifically, we would like to receive comments from stakeholders on the following aspects of the documents:

Join in: how to participate

Participate by mail - Send a letter with your input to the address in the contact us section below.

Participate by email - Send an email to with your comments.

Who is the focus of this consultation

We will engage with:

  • Interested public parties
  • Healthcare professionals 
  • Medical device manufacturers

Key questions for discussion

Health Canada would like you to participate by providing feedback with respect to the Draft Guidance Document for Software as a Medical Device (SaMD).

Your feedback is sought regarding the overall clarity and content of the draft guidance document.  More specifically, we would like to get your feedback on the following sections of the documents, as they relate to the regulation of SaMD in Canada:

  • Inclusion Criteria
  • Exclusion Criteria
  • Classification of SaMD
  • Examples of SaMD

Related information

Contact us

Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
11 Holland Ave, Tower A
Address locator: 3002A
Ottawa, ON K1A 0K9

Telephone: 613-957-7285
or email:

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