🇨🇦Canada Medical Device Regulations

Guidance for Labelling of Medical Devices

Detailed guidance on medical device labeling including e-labeling provisions for professional-use devices, symbol requirements, and bilingual requirements for consumer devices.

Medical Device Single Audit Program

Mandatory MDSAP certification for Class II-IV device manufacturers since January 2019. Replaces CMDCAS. Single audit satisfies Canada, USA, Brazil, Japan, and Australia requirements.

Medical Devices Regulations

Primary regulation governing medical devices in Canada. Establishes classification (Class I-IV), licensing requirements, establishment licensing (MDEL), and post-market obligations.

Medical Device Establishment Licence (MDEL)

MDEL requirements for manufacturers (Class I) and importers/distributors (all classes). Annual renewal required. CAD $5,426 application fee (2025).

Medical Device Licence (MDL)

MDL requirements for Class II, III, and IV devices. Requires MDSAP certificate, device description, labeling, and safety/effectiveness evidence. Fees: Class II CAD $632, Class III CAD $13,926, Class IV CAD $30,199.

Medical Device Labeling Requirements

Labeling requirements including bilingual (English/French) for consumer devices, manufacturer identification, device description, and directions for use. ISO 15223-1 symbols accepted.

Mandatory Problem Reporting (MPR)

Mandatory adverse event reporting for manufacturers and importers. Hospitals must report serious incidents within 30 days. Includes recall and field action requirements.

In Vitro Diagnostic Device Classification

Classification rules for IVD devices based on risk. Includes specific rules for blood group, infectious disease, and companion diagnostic tests.