Examples of Software as a Medical Device Classification – Health Canada Guidance

Purpose of the Examples

Health Canada’s SaMD guidance includes practical examples to illustrate how software is assessed for medical device status and risk classification. These examples help manufacturers, developers, and regulators apply the definitions and classification rules consistently, particularly for standalone software used on general-purpose platforms. The examples are non-exhaustive but demonstrate key decision points related to intended use, clinical function, and potential patient impact. Examples - Canada.ca

Key Decision Criteria Illustrated

• Does the software have a medical purpose (diagnosis, treatment, prevention, monitoring, etc.)?
• Is the software standalone (not part of a hardware device)?
• What is the healthcare situation or condition addressed?
• What is the potential consequence of incorrect output or action?

Selected Examples and Classifications

Example 1: Symptom Tracking App

Software that allows users to log symptoms (e.g., pain levels, mood) and view trends without providing diagnosis or treatment recommendations.

• Classification: Not a medical device (general wellness or data logging only).
• Rationale: No medical purpose beyond self-monitoring; no modification or analysis leading to clinical decisions.

Example 2: Mobile App for Blood Pressure Interpretation

Software that records blood pressure readings from a connected device and provides interpretive messages (e.g., “high blood pressure detected – consult physician”).

• Classification: Class II medical device.
• Rationale: Provides diagnostic information; incorrect output could lead to delayed care but not serious injury.

Example 3: Radiation Treatment Planning Software

Standalone software that uses patient imaging data to calculate and optimize radiation therapy plans.

• Classification: Class IV medical device.
• Rationale: Controls delivery of potentially life-sustaining treatment; errors could cause serious injury or death.

Example 4: Software for Continuous Glucose Monitoring Analysis

Software that analyzes data from a continuous glucose monitor and provides alerts for hypo/hyperglycemia.

• Classification: Class III medical device.
• Rationale: Monitors a serious condition; incorrect alerts could lead to serious health deterioration.

Example 5: Image Processing Software for X-ray Enhancement

Software that enhances X-ray images for better visualization but does not provide diagnostic conclusions.

• Classification: Class II medical device.
• Rationale: Intended to assist diagnosis; errors may affect interpretation but are unlikely to cause serious harm directly.

Example 6: General Fitness Tracker with Heart Rate Monitoring

Wearable software that tracks heart rate and activity for fitness purposes only.

• Classification: Not a medical device (unless marketed with medical claims).
• Rationale: Intended for general wellness; no specific medical purpose claimed.

Practical Application

• Use these examples to map your software’s intended use and functionality.
• Document the classification rationale in your quality management system.
• For borderline cases, seek pre-submission consultation with Health Canada.
• Reassess classification when software updates change intended use or risk profile.

These examples support consistent application of SaMD classification rules and help stakeholders understand regulatory expectations. Full details, additional scenarios, and decision flowcharts are available in the official Health Canada SaMD examples document. Examples - Canada.ca