Software as a Medical Device (SaMD) Classification and Registration

Based on risk evaluation as well as inclusion and exclusion criterion, our medical device license experts will assist in registering your SaMD with Health Canada

30 Minutes Free Consultation

Software as a Medical Device - Classification and Registration in Canada

Health Canada defines software as a medical device (SaMDas a software intended to be used for one or more medical purposes and performs these purposes without being part of a hardware medical device. SaMD includes in-vitro diagnostic (IVD) medical devices and can run on non-medical computing platforms.

There are inclusion and exclusion criteria that must be met to determine if a device meets the definition of an SaMD. Health Canada follows standards developed by the International Medical Device Regulators Forum (IMDRF) in this criterion determination if the software is a medical device.

SaMD can apply to any of the four classes of medical devices that are under the classification system in Canada.

IEC 62304 Standard and Software Risk Classification for SaMD

The standards followed by Health Canada for SaMD is IEC 62304.  This harmonized standard is specifically created for medical device software.  There are 3 levels of software risk that Health Canada follows for SaMD (FDA follows 4 levels of software risk).  These 3 levels are defined as follows:

Class A – no injury, death or hazardous outcome possible

Class B –  no serious injury outcome though a hazardous situation is possible

Class C – death or serious injury is possible through a hazardous situation

This risk analysis and determination requires extensive documentation to support the class in which the device software falls into.

Software as a Medical Device
SaMD

FDA Software Risk Classification based on IEC 62304

There are 4 risk categories for SaMD under the FDA framework.

Category 1 – Low impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 2 – Medium impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 3 – High impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 4 – Very high impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

How Quality Smart Solutions can assist with your SaMD registration

The first step in our process is determining what class your device is and secondly, determining what risk classification your SaMD falls under based on the country of registration.

Upon determining class and risk categorization, a technical dossier will be prepared following IEC 62304 standards.  When the technical dossier is completed, the medical device license application (if applicable) is prepared for submission to Health Canada and/or FDA.

Software as a Medical Device

Frequently Asked Questions

Health Canada defines software as a medical device (SaMD)  as a software intended to be used for one or more medical purposes and performs these purposes without being part of a hardware medical device.  SaMD includes in-vitro diagnostic (IVD) medical devices and this software can run on non-medical purpose computing platforms.

There are inclusion and exclusion criteria that must be met to determine if they meet the definition of a SaMD. Health Canada follows standards developed by the International Medical Device Regulators Forum (IMDRF) in this criterion determination if the software is a medical device.

SaMD can apply to any of the four classes of medical devices that are under the Health Canada medical device classification system.

Software as a Medical Device (SaMD) is software that is used for at least one medical purpose but is not a part of a medical device’s hardware.  This type of software is defined by the Medical Device Regulations Forum (IMDRF).  The only pre-requisite for obtaining registration is the existence of an ISO 13485 certificate.  To learn the full process for registering your SaMD contact us at info@qualitysmartsolutions.com.

The standard followed by Health Canada for SaMD is IEC 62304.  This harmonized standard is specifically created for medical device software. 

There are 3 levels of software risk that Health Canada follows for SaMD (FDA follows 4 levels of software risk).  These 3 levels are defined as follows:

Class A – no injury, death, or hazardous outcome possible

Class B – no serious injury outcome though a hazardous situation is possible

Class C – death or serious injury is possible through a hazardous situation

This risk analysis and determination requires extensive documentation to support the class into which the device software falls.

There are 4 risk categories for SaMD under the FDA framework.

Category 1 – Low impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 2 – Medium impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 3 – High impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Category 4 – Very high impact SaMD that provides information to drive and/or inform clinical management for a disease or conditions in a serious or non-serious situation or condition.

Need SaMD Registration Assistance in Canada or the US?

Please complete the form below. We will respond to you soon.

Select all applicable Services
Select countries of interest
Attend Webinar: June 27 @2PM EST

FDA & Health Canada (CFIA) Requirements To Sell Foods in North America

Andrew Parshad
Founder & President
Mitch Kiernan
Quality & Regulatory Affairs Specialist
This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.