Labelling Requirements for Medical Devices Including In Vitro Diagnostic Devices – Health Canada Guidance

Purpose and Legal Basis

This guidance document provides detailed requirements for labelling medical devices, including in vitro diagnostic (IVD) devices, under sections 21 to 23 of the Medical Devices Regulations. Proper labelling ensures users have necessary information for safe and effective use, including identification, instructions, warnings, and contraindications. The guidance covers labels on the device itself, outer packaging, and accompanying materials (e.g., instructions for use, operator manuals). Guidance on Labelling of Medical Devices Including In Vitro Diagnostic Devices - Appendices - Canada.ca

Core Labelling Requirements

All medical devices must include:

• Device Name and Identifier: Name, model/catalogue number, or unique device identifier (UDI) if applicable.
• Manufacturer Information: Name and address of the manufacturer or authorized representative in Canada.
• Intended Use/Purpose: Clear statement of what the device is intended to do.
• Warnings and Precautions: Information on risks, contraindications, limitations, and safe handling.
• Storage and Handling Conditions: Temperature, humidity, light protection, or other requirements.
• Sterility Status: If applicable, indication of sterile condition and sterilization method.
• Expiry Date or Shelf Life: For devices with limited shelf life.
• Single-Use Statement: If the device is intended for single use only.

Special Requirements for IVD Devices

IVD labelling must additionally include:

• List of Reagents or Components: For kits, complete list of reagents, calibrators, controls.
• Performance Characteristics: Sensitivity, specificity, precision, or other relevant parameters.
• Sample Type and Volume: Acceptable specimen types and required volumes.
• Interpretation of Results: Clear instructions on how to read and interpret test results.
• Limitations of the Procedure: Known interferences, cross-reactivity, or limitations.

Language and Format Requirements

• Labels must be in English and French, or provide both languages in accompanying materials.
• Text must be legible, permanent, and prominently displayed.
• Symbols may be used if explained in accompanying materials (reference to ISO 15223-1 recommended).

Appendices and Practical Guidance

• Appendix A: Examples of minimum labelling requirements by device class and type.
• Appendix B: Specific labelling for custom-made devices and systems.
• Appendix C: Guidance on UDI implementation and barcoding.
• Appendix D: Special considerations for software-containing devices and combination products.

Practical Considerations

• Labelling must remain accurate throughout the device lifecycle; changes affecting safety or performance require notification or new licence.
• Distributors and importers must ensure labelling complies before market entry.
• Electronic labelling (e-label) may be acceptable for certain devices if users have reliable access.
• Maintain records of labelling versions for post-market surveillance.

This guidance helps manufacturers, importers, and distributors meet labelling obligations to protect public health and support safe device use. Full details, including examples, symbol explanations, and regulatory references, are available in the official Health Canada labelling guidance document and its appendices. Guidance on Labelling of Medical Devices Including In Vitro Diagnostic Devices - Appendices - Canada.ca