March 18, 2020 – Health Canada published a guidance document on Software as a Medical Device (SaMD): Definition and Classification. The guidance documents is intended for medical device manufacturers, importers, distributors, healthcare professionals and interested parties on Health Canada’s Medical Devices Regulations.
This 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 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.
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
Email: hc.devicelicensing-homologationinstruments.sc@canada.ca
Telephone: 613-957-7285
Fax Number: 613-957-6345