Bilingual Labelling Requirements
Legal basis
Canada's Official Languages Act and the Consumer Packaging and Labelling Act require that consumer product labels be in both English and French. For medical devices, Health Canada applies this requirement to all device labelling, including:
- Physical labels on the device and packaging
- Instructions for Use (IFU)
- Package inserts
- Promotional/technical materials given to users
This is one of the most commonly overlooked requirements for foreign manufacturers entering the Canadian market.
What must be bilingual
| Labelling element | Bilingual required? |
|---|---|
| Device name | Yes |
| Manufacturer name/address | Address elements typically in English only, name bilingual if descriptive |
| Intended use / indications | Yes |
| Warnings and precautions | Yes |
| Storage conditions | Yes |
| Instructions for use | Yes |
| Lot/serial number | No (numeric/alphanumeric — no translation required) |
| Expiry date | Yes (format, not just numbers) |
| Sterility indication | Yes |
| MRI safety symbols | Symbols OK; accompanying text must be bilingual |
Practical approach
For foreign manufacturers, the most practical approach is:
- Develop bilingual labels from the outset rather than translating English-only labels
- Use professional translation by translators familiar with medical/regulatory terminology
- Have translations reviewed by a Canadian French-speaking regulatory professional
- Note that Québec French differs from international French — terminology should be appropriate for Canadian usage
Device Licence application
Bilingual labels must be included in the Device Licence application. A submission with English-only labels will receive a Screening Deficiency Notice and the review clock will not start until bilingual labels are provided.
Labelling updates
If bilingual labels are updated after licence issuance, assess whether the update requires a Device Licence amendment. See Amending a Device Licence.
Legislative source: Official Languages Act, RSC 1985, c 31 (4th Supp); Consumer Packaging and Labelling Act, RSC 1985, c C-38; Medical Devices Regulations, SOR/98-282, s 21