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Other Relevant Instruments

Consumer Product Safety Act (CPSA)​

The Canada Consumer Product Safety Act (SC 2010, c 21) regulates consumer products that pose an unreasonable danger to human health or safety. Most medical devices are excluded from the CPSA (they are regulated under the FDA), but some borderline products may fall under both.

Hazardous Materials Information Review Act (HMIRA)​

Relevant for manufacturers using controlled or hazardous materials in device manufacturing. Workplace safety data sheets (SDS) for hazardous chemicals used in manufacturing must comply with WHMIS (Workplace Hazardous Materials Information System) requirements.

Weights and Measures Act​

Relevant for medical devices with a measuring function used in commercial transactions. Measuring instruments (including some medical measurement devices) may require type approval under the Weights and Measures Act.

Privacy legislation (PIPEDA / provincial privacy laws)​

Manufacturers of connected medical devices (IoT devices, remote monitoring systems, SaMD) must consider:

  • Personal Information Protection and Electronic Documents Act (PIPEDA) — federal privacy law governing collection, use, and disclosure of personal health information in commercial activities
  • Provincial health privacy laws (e.g., PHIPA in Ontario, FOIPPA in BC) — apply to healthcare providers and insurers using the device data

Official Languages Act​

Requires bilingual labelling (English and French) for medical devices sold to Canadian consumers. See Bilingual Requirements.

Competition Act​

Advertising claims for medical devices must comply with the Competition Act's provisions on misleading advertising and deceptive marketing practices, in addition to the FDA advertising provisions.

Patent Act​

Patent protection is available for novel medical device technologies. Patents do not affect Health Canada regulatory requirements but are commercially important for device manufacturers.