Supporting Evidence for New or Amended Licence Applications – Class II, III, IV Medical Devices and IVDs – Health Canada Guidance

Purpose and Scope

This guidance document outlines the evidence Health Canada expects in applications for new medical device licences or significant amendments for Class II, III, and IV devices, including in vitro diagnostic devices (IVDs). The level of evidence is proportionate to the device’s risk classification and the type of change proposed. The document applies to licence applications under sections 32 to 36 of the Medical Devices Regulations and helps ensure consistent, risk-based review of safety, effectiveness, and quality. Guidance Document: Supporting Evidence for New or Amended Licence Applications for Class II, III, IV Medical Devices Including In Vitro Diagnostic Devices - Canada.ca

General Principles

Evidence requirements increase with device risk class:

• Class II: Focus on quality system, labelling, and basic performance data.
• Class III: Additional emphasis on design validation and clinical evidence.
• Class IV: Comprehensive clinical data, risk management, and long-term safety/performance evidence.

Evidence must be generated under conditions representative of intended use and comply with recognized standards (e.g., ISO 13485, ISO 14971, IEC 62304 for software).

Key Evidence Categories

1. Device Description and Intended Use

• Detailed description of design, materials, components, and accessories.
• Clear statement of intended use, indications, contraindications, and target population.
• Comparison to predicate devices (if applicable).

2. Risk Management

• Risk analysis per ISO 14971, including hazard identification, risk evaluation, and mitigation controls.
• Post-market surveillance plan for higher-risk devices.

3. Quality Management System

• Evidence of compliance with ISO 13485 or equivalent.
• Manufacturing process validation and control data.

4. Performance and Effectiveness

• Bench testing, preclinical studies, and verification/validation data.
• Software validation (if applicable) per IEC 62304.
• Clinical evidence proportionate to risk: literature review for low-risk modifications; full clinical studies for novel high-risk devices.

5. Labelling and Instructions for Use

• Draft labelling compliant with regulations.
• User instructions, warnings, and training materials.

6. Amendments – Specific Evidence

• For design changes: Updated risk analysis and verification/validation data.
• For labelling changes: Justification and impact assessment.
• For new indications: Clinical evidence supporting the expanded use.

Practical Considerations

• Use the Medical Device Licence Amendment Application Form for changes.
• Submit only relevant evidence; excessive data may delay review.
• For IVDs, include diagnostic accuracy studies, specimen stability data, and interference testing.
• Engage in pre-submission meetings for complex or novel devices.

This guidance promotes efficient, risk-proportionate evidence submission while ensuring patient safety and device performance. Detailed tables of evidence by class, amendment type, examples, and regulatory references are provided in the official Health Canada document. Guidance Document: Supporting Evidence for New or Amended Licence Applications for Class II, III, IV Medical Devices Including In Vitro Diagnostic Devices - Canada.ca