ABSTRACT
The Canadian government derives its authority to regulate medical devices from the Food and Drugs Act (F&DA). The requirements for labeling of the medical devices sold in Canada are contained in the Canadian “Medical Devices Regulations” (CMDR). These regulations are published in the Canada Gazette, Part II – Statutory Orders and Regulations as SOR/98-282. These general requirements may be supplemented by particular requirements in guidance documents issued by the Therapeutic Products Directorate (TPD), in performance and safety standards for medical devices established by the TPD, or in standards recognized by the TPD as demonstrating that a medical device meets minimum safety and effectiveness requirements.
