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SOR/98-282 Part 21 Rules
Canadian Labelling, French/English & IFU Compliance
Canadian labelling requirements are not a translation exercise. The label, package, instructions for use and promotional claims must remain consistent with the licensed device, intended use and performance evidence.
Our Labelling Review Includes
Device name and legal manufacturer identity
Device identifier and catalogue/model information
Intended use and directions for use
Warnings, precautions, contraindications and limitations
Sterility, storage and expiry information where applicable
Primary and secondary packaging artwork
IFU and package inserts
IVD performance specifications where applicable
Near-patient IVD labelling considerations
Electronic labelling strategy where eligible
Alignment of claims with the licensed indications and evidence package
English/French language requirements based on the intended user and sales channel
Language Requirement:
For devices sold to the general public, specified label information and directions for use must be available in both English and French. For other devices, labelling may be in either official language, with the other official language made available on request. Near-patient IVD requirements should be assessed separately.
Audit Your Artwork and IFUs for Health Canada Compliance
Our labelling team reviews bilingual requirements, packaging legibility, symbol alignment, and electronic labelling.