Health Canada Bilingual Labeling Translation
Bring your drug, medical device, natural health product or food to the Canadian market with accurate English–French labeling. Regulatory-grade Canadian French translation, reviewed by specialists.
✅ Free quote · ⚕️ Regulatory terminology · 🍁 fr-CA + bilingual · 🔒 Confidential / NDA
Does Health Canada require bilingual (English–French) labeling?
Yes. Federal rules require key label information in both English and French for products such as drugs, medical devices, natural health products and most consumer foods sold in Canada. This is separate from Quebec's Bill 96 — it applies nationwide. We translate your labeling to regulatory standards in Canadian French.
- Bilingual labeling for drugs, devices, NHPs and food
- Federal requirement, nationwide — distinct from Quebec Bill 96
- Regulatory terminology and consistent fr-CA wording
- Confidential handling under NDA for pre-market documents
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What we translate for regulated products
Drug & NHP labels
Inner/outer labels, package inserts, dosage, warnings and product monographs.
Medical device labeling
Device labels, IFUs (instructions for use), packaging and patient materials.
Food & supplement labels
Ingredient lists, nutrition facts tables, claims and allergen statements.
Patient & consumer info
Patient information leaflets, consumer guides and safety communications.
Regulatory submissions
Supporting documentation and correspondence requiring a French version.
Marketing & professional
HCP materials, monograph summaries and promotional copy, fr-CA.
Why regulated companies trust us
- Specialist medical/pharma linguists, not generalists.
- Regulatory terminology consistency via maintained glossaries.
- Certified translations (OTTIAQ / ATIO) when an attestation is required.
- Confidential, NDA-backed handling of pre-market and proprietary content.
Frequently asked questions
Is Health Canada bilingual labeling the same as Quebec Bill 96?
No. Health Canada bilingual labeling is a federal requirement that applies across Canada for regulated products. Bill 96 is a Quebec law about the predominance of French. Many products must satisfy both; we handle each correctly.
- Federal vs Quebec rule
- Both may apply
- We cover both
Do you provide certified translations for submissions?
Yes. When an official version or attestation is required, our OTTIAQ / ATIO certified translators provide certified translations with seal and statement.
- OTTIAQ / ATIO certified
- Seal + attestation
- For submissions when required
How do you ensure regulatory accuracy?
We assign specialist medical and pharmaceutical linguists, maintain product-specific glossaries and translation memory, and apply a review step so terminology stays accurate and consistent across documents.
- Specialist linguists
- Glossary + TM
- Review step
Is my pre-market information kept confidential?
Yes. We handle proprietary and pre-market content under NDA, with controlled access and secure file transfer.
- NDA standard
- Controlled access
- Secure transfer
Asiatis provides documentary and linguistic services. Regulatory requirements summarized here are for guidance; confirm specific labeling obligations with Health Canada or your regulatory advisor.