Health Canada has written a guide for regulating software as medical devices (SaMD). They are now asking for input on their regulations by healthcare professionals, medical device developers, and interested public parties until March 29, 2019. This guidance comes at a great time, given how rapidly software is evolving today and how blurry the lines can be on their regulation.
Specifically, Health Canada is asking for input on their inclusion criteria, exclusion criteria, and classifications. They’re also asking for current examples of SaMD that can help aid in understanding the proposed regulations.
They list inclusion criteria for software as a medical device as being intended to be used for medical purposes without being part of a hardware medical device. “Medical purposes” are defined further as intention to acquire, process, or analyze medical images or information from monitoring/imaging/in vitro diagnostic devices. These purposes also include supporting/recommending health care professionals about the overall care and treatment of patients.
The listed exclusion criteria include administrative software for facilities, communication software including patient registration, scheduling, and calling, wellness software apps, and database software including EMRs.
Once determined as a SaMD, software has to be further classified into its use and risk class, with software for non-serious conditions having the lowest risk classes I or II, and software for critical conditions having the highest risk class III.
This follows the U.S. FDA’s guidance on SaMDs released in 2017.
You can advise Health Canada through email or regular mail.
Medical Devices Bureau
Therapeutic Products Directorate
11 Holland Ave, Tower A
Address locator: 3002A
Ottawa, ON K1A 0K9