Consultation on draft guidance document for software as a medical device (SaMD)

Current status: Closed

This consultation ran from January 23 to March 29, 2019

Who was the focus of this consultation

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Health Canada would like you to participate by providing feedback with respect to the Draft Guidance Document for Software as a Medical Device (SaMD).

Your feedback is sought regarding the overall clarity and content of the draft guidance document.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

What we heard

To request a copy of the comment chart, please contact mddpolicy-politiquesdim.sc@hc-sc.gc.ca

Related information

• Food and Drug Act
• Medical Device Regulations
• Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
• Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)

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: meddevices-instrumentsmed@hc-sc.gc.ca