Canada – Health Canada Seeks to Better Define Regulatory Requirements for SaMD

Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD).

Health Canada notified industry last year of its intent to release draft guidance on SaMD as part of a larger initiative to improve regulatory reviews. The timeline, however, was delayed after a Health Canada scientific advisory panel raised concerns over the previous approach, which would have partly modeled certain SaMD policies on those previously developed by Australia’s Therapeutic Goods Administration (TGA).

The draft guidance indicates that Health Canada has pivoted away from using some TGA policies for in vitro diagnostic SaMD. The 15-page document makes certain references to US Food and Drug Administration (FDA) guidance documents related to SaMD, seeking alignment with FDA’s exclusion criteria after these received modifications via the 21st Century Cures Act of 2016. With TGA’s December 2018 release of SaMD guidance, TGA signaled needed updates to Australia’s classification regulations to better reflect SaMD risk. 

The draft guidance represents the agency’s response to the booming global digital health sector, which has resulted in a growing body of software products intended for patient and/or provider use. These policy clarifications were developed as Health Canada’s interpretations of the Food and Drugs Act regulations and of the five-year-old SaMD definition developed via the International Medical Device Regulators Forum (IMDRF).

The draft guidance clarifies that the “functionality of any software product and the manner in which it is represented or labeled for use, dictates whether it qualifies as a medical device under Health Canada’s regulations.”..