ABSTRACT
All Medical Devices sold in Canada must be in compliance with the Food and Drugs Act, Medical Device Regulations, published in July, 1998, Registration SOR/98-282 7 May, 1998. The Medical Devices Regulations prepared by the Medical Device Bureau, Health Protection Branch, set out the requirements governing the sale, importation, and advertisement of medical devices. The Medical Devices Regulations are administrated by the Therapeutic Products Programme, which recognizes and strongly endorses the importance of harmonization as a key factor of the Medical Devices Regulations. The Medical Devices Regulations distinguish medical devices under a risk-based classification system. For the designer familiar with the European Union Medical Device Directive, it is evident from the described Canadian classification system, that both systems are almost identical. The unique requirements in the Medical Device Regulations are labeling, since Canada is a bilingual country. In the process in designing of medical equipment the knowledge, use and application of applicable standards are essential.
