Medical device regulation in Canada: direction for change

The medical device regulatory programme in Canada was first instituted in 1975. Recently this programme underwent a review. This paper first describes the system of regulations as it has been administered by the Health Protection Branch of the government of Canada. The rationale for the establishment of the Medical Devices Review Committee, its deliberations and report are then discussed. Finally, the paper examines measures currently being taken to implement recommendations that will take the regulatory programme for medical devices in Canada into the twenty-first century.