We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy. Learn more here.Close Me
Health Canada has published a draft guidance (Guidance) on the
regulation of Software as a Medical Device (SaMD).1 The
Guidance will apply to any software sold within the meaning of
Food and Drugs Act, which Health Canada indicates would
typically require transfer of ownership from one party to another
and would include downloading software from an online store to a
mobile device.
What you need to know
Health Canada will consider software to be a medical device
when: (a) it is intended to be used for a medical purpose and (b)
it performs its purposes without being part of a hardware medical
device (i.e., the software is not necessary for a hardware medical
device to achieve its intended medical purpose).
A software developer producing a SaMD under its own name or
trademark is considered to be a manufacturer under the Regulations,
and would be responsible for regulatory compliance.
Stakeholders have been invited to provide comments to Health
Canada on the Guidance by March 29.
Summary
The Guidance is intended to provide needed clarity to industry
on when a medical device license is necessary for SaMD. The risk
classification of the SaMD, which determines the category of
medical device licenses needed for marketing approval, is
established by considering the significance of information provided
by the SaMD (in the context of a healthcare decision) and the state
of the healthcare situation (critical, serious or non-serious).
The Guidance includes the following key points.
Inclusion criteria
Software will be considered SaMD if:
it is intended to be used for a medical purpose(s); and
it performs these purposes without being part of a hardware
medical device.
Note that Health Canada interprets "medical purposes"
as acquiring, processing or analyzing medical images or information
from in-vitro diagnostic (IVD) medical devices, and supporting or
providing recommendations about the prevention, diagnosis,
treatment or mitigation of a disease to health care professionals,
patients or caregivers.
Exclusion criteria
Software will not be considered SaMD if it is:
not intended to acquire, process or analyse a medical image or
information from an IVD device;
intended to display, analyse or print medical information
(e.g., software that provided relevant reference information based
on the patient's symptoms or care plan);
only intended to support a health care professional, patient or
caregiver in prevention, diagnosis or treatment decisions; and
not intended to replace clinical judgment.
Note that Health Canada interprets "support" as the
provision of information that does not trigger an immediate
action.
Continuing exclusions
Health Canada will continue to exclude the following types of
software from regulation as a medical device:
software intended for administrative support of a healthcare
facility,
software to enable clinical communication and workflow,
software for maintaining or encouraging a healthy lifestyle
(e.g., an app that tracks calorie intake); and
software serving as electronic patient records.
Classification
Each SaMD will be independently classified, even if it
interfaces with other devices or is used as part of a large
system.
Non-IVD SaMD will be classified as Class I, II or III devices
based on their intended use. The classification will depend on the
severity of the healthcare situation in which the SaMD is used and
the significance of the information provided by the SaMD. For
example, SaMD used in critical healthcare situations and provides
treatment or diagnosis information are regulated as a Class III
device under the proposed framework.
IVD SaMD will be classified according to the classification
rules applied to conventional IVD devices.
Health Canada has also published a list of example
classifications for comment.2
Comments may be submitted by email to
hc.mdb.enquiries-enquetes.bmm.sc@canada.ca or by mail to the
Medical Devices Bureau by the March 29 deadline.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Following the recent legalization of recreational cannabis in Canada, now is a good time for Canadian employers to review their workplace policies to ensure ...
Starting in the first quarter of this year, Suncor Energy Inc. (Suncor) plans to start randomly testing some of its employees for drugs and alcohol at its northern Alberta worksites.
Brave New Workplace: The Legalization Of Recreational Marijuana In Canada (Video)
