Software as a Medical Device (SaMD) Classification and Registration

Based on risk evaluation, inclusion and exclusion criterion our software device licence experts will assist in registering your saMD with Health Canada and FDA.

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Software as Medical Device Classification and Registration in Canada

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

There are inclusion and exclusion criterion  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.

IEC 62304 Standard and Software Risk Classification for SaMD Health Canada

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 – deaht 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.

Standard and Software Risk Classification for SaMD Health Canada
FDA Software Risk Classification

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 registration is determining what class your device is and secondly, to determine 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 licence application (if applicable) is prepared for submission to Health Canada and/or FDA.

SaMD registration

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