Notice: Guidance Document: Software as a Medical Device (SaMD): Definition and Classification

December 18, 2019
Reference: 19-121801-976

Health Canada is pleased to announce the finalization of the guidance document on Software as a Medical Device (SaMD): Definition and Classification. Guidance documents explain to companies how to meet Health Canada’s regulations.

This guidance document clarifies how SaMD fits into Health Canada’s regulatory framework for medical devices, based on current interpretation of the definitions of “device” and “medical device” in the Act and Regulations.  It provides detailed information to companies on what is regulated as SaMD, and what is not.

This guidance is the first step of SaMD policy in Canada, and Health Canada will update its policy on these devices as the technology evolves.

Companies should consult this guidance when they prepare SaMD applications for Health Canada. It provides information on SaMD classification and includes several examples.  The classification of a SaMD is based on what the software will be used for, combined with the Classification Rules found in the Medical Devices Regulations.

Health Canada tried to harmonize the classification of SaMD with the regulations of other countries, where possible. Harmonizing Canada’s regulations with the regulations of other countries makes it easier for companies to sell their product in more than one country.

The draft version of this document was posted on Health Canada’s website on January 23, 2019 for a 60-day consultation. Stakeholder comments received on the draft version of this document were considered in the finalization of this guidance document. A summary of comments received is available upon request.

This guidance document is effective immediately.

Questions?

Please direct questions or concerns regarding this guidance document to:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
11 Holland Avenue
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9