Health Canada Establishing Regulatory Framework for Software as a Medical Device (SaMD)
Regulatory Updates | Digital Health Products, Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- Health Canada proposing regulatory requirements for software as a medical device (SaMD).
- Proposed Health Canada regulations for SaMD based on International Medical Device Regulators Forum (IMDRF) guidelines.
- Health Canada SaMD regulations would exclude products such as electronic health records and wellness apps.
Canadian healthcare market regulators have drafted proposed market authorization requirements for software as a medical device (SaMD) and related technologies.
Health Canada is seeking stakeholder comment on its SaMD draft guidance through March 29, 2019. The agency intends to establish how the country’s existing Canadian Medical Devices Regulations (CMDR) can best accommodate SaMD in terms of definitions, risk classification, oversight and related issues.
The agency’s SaMD draft guidance follows proposed premarket cybersecurity requirements for Medical Device License (MDL) applicants published in late 2018.
The Health Canada guidance bases its definition of SaMD on International Medical Device Regulators Forum (IMDRF) recommendations:
- SaMD is intended for use for one or more medical purposes as defined by Canadian regulations;
- SaMD performs medical purposes without acting as a component of another medical device.
“Medical purposes” that qualify software as a SaMD product include those such as processing or analyzing medical images, IVD data or measurements from other devices, as well as purposes of supporting healthcare professionals, patients and caregivers treat, diagnose or prevent diseases or conditions.
Based on these criteria, Health Canada considers two broad categories of software as qualifying for the SaMD definition: clinical decision support software (CDS) and patient decision support software (PDS).
Examples of what Health Canada considers SaMD
Health Canada also provides examples of SaMD products in each medical device classification category:
- Class I SaMD: Mobile software applications that receive alerts from hospital event management software indicating a patient monitor alarm
- Class II SaMD: Software that collects patient data such as blood pressure or weight from connected medical devices and transmits them to healthcare professionals for remote patient monitoring
- Class III SaMD: Software for diagnostic image analysis to support treatment decisions for acute conditions such as stroke
The regulator has also identified types of software that would not fall under Canadian medical device regulations as SaMD: administrative support software, software for patient registration and scheduling, and general wellness apps, for example.
Examples of products excluded from Health Canada’s SaMD definition include “lifestyle apps” allowing users to track their own basic health information; electronic health records (EHR); software considered Medical Device Data Systems (MDDS); and chat-based triage software providing users with recommendations based on medical symptoms.
How Health Canada would classify SaMD products
According to the draft guidance, Health Canada would apply the same CMDR classification rules to SaMD products as it does to other medical devices in most cases. Certain SaMD products will fall under Canadian classification rules for IVD devices as appropriate.