Health Canada has implemented a European-based process for inspecting and determining a firm’s quality system compliance status while maintaining a US-like system of firm inspection. As such, any firm interested in selling its products in Canada must comply with ISO-13845:2003 and support its regulatory compliance by allowing Health Canada or European Registars inspections.
GEMAR’s experience in the development, documentation, implementation and certification of quality systems to Canadian requirements will ensure that your firm will move along the most efficient road to Health Canada and in turn Canadian acceptance of your quality system.