Labelling Requirements
Overview
All medical devices sold in Canada must carry a label meeting the requirements of the Medical Devices Regulations (ss 21–26). Labelling includes:
- The physical label on the device and its packaging
- Instructions for Use (IFU)
- Any accompanying documentation (e.g., user guides, quick reference guides)
- Electronic labelling (when permitted) All labelling elements must collectively provide the information necessary for safe and effective use.
Mandatory label content
The following information must appear on the label of all medical devices (Class I–IV):
| Item | Requirement |
|---|---|
| Device name | The name under which the device is sold |
| Manufacturer name and address | Legal name and full address |
| Lot number or serial number | For traceability |
| Expiry date | Where applicable |
| Single-use designation | If intended for single use only |
| Sterility indication | If supplied sterile (must state sterilisation method) |
| Instructions for use | Adequate directions for safe use |
| Warnings and precautions | Necessary safety information |
| Storage conditions | If special storage required |
Additional content for specific device types
Implantable devices
- Implantation instructions
- Materials of construction
- MRI safety information (MR Safe / MR Conditional / MR Unsafe)
IVD devices
- Intended analyte(s) and specimen type(s)
- Performance characteristics
- Reagent composition
- Quality control requirements
- Limitations
Instructions for Use (IFU)
IFUs are part of the label. They must:
- Be written in plain language appropriate for the intended user
- Be bilingual (English and French)
- Cover intended use, contraindications, warnings, step-by-step instructions, troubleshooting, cleaning/disinfection/sterilisation
Electronic IFUs (eIFU) are permitted for certain device types, including mobile apps and online portals, consistent with IMDRF guidance. However, a paper IFU or a readily accessible electronic copy must still be available on request at no cost to the user.
Legislative source: Medical Devices Regulations, SOR/98-282, ss 21–26
Electronic labelling (e-labelling)
For devices sold or distributed through digital channels, electronic labelling is permitted provided:
- The e-labelling contains all mandatory information that would appear on a physical label
- The e-labelling is readily accessible to the user prior to purchase and throughout the product lifetime
- The information is presented in a format that is clear, legible, and cannot be altered by the user
- A paper version of the IFU must still be available upon request
Label placement and legibility
Labels must be: Securely affixed to the device or its packaging Legible and indelible In a font size and contrast that ensures readability by the intended user Placed in a location visible and accessible to the user before and during use
Abbreviated labelling (quick reference labels)
For certain Class I and II devices, an abbreviated label may be acceptable if: The device is simple and its use is self-evident A full IFU is available on packaging, in labelling, or online The abbreviated label contains essential safety information and directions for use Health Canada has approved the abbreviated format in the Device Licence