In August 2009, Health Canada announced that all patient management software “involved in data manipulation, data analysis, data editing, image generation, recording of measurements, graphing, flagging of results or performing calculations is considered as a Class II medical device.” Alongside the ongoing challenge of meeting provincial requirements for approval, Canadian EMR vendors must now work to achieve International Organization for Standardization (ISO) certification in order to sell products in the Canadian market.

What Just Happened?

Health Canada specified that vendors will have twelve months to comply with ISO standard 13485:2003, which regulates quality management practices for vendors marketing medical devices. EMR vendors with Class II offerings must demonstrate that their internal quality control practices meet customer and regulatory requirements outlined by the ISO standard before gaining entry in the Canadian market.