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
Manufacturer name/address Yes (all elements must be bilingual, including name and full address)
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
Foreign manufacturers should prioritize bilingual label development early in the regulatory process. Health Canada does not provide grace periods for English-only submissions; incomplete bilingual labelling will result in a Screening Deficiency Notice and clock suspension from the date of submission.