Health Canada Issues New Reporting Requirements for Hospitals
Hospitals will be required to report serious adverse drug reactions and medical device incidents to Health Canada within 30 days after the incidents are documented within the institutions.
New regulations that apply to hospitals in Canada will require them to report serious adverse drug reactions and medical device incidents to Health Canada within 30 days after the incidents are documented within the institutions. Announced June 26, the regulations will take effect in late 2019.
Health Canada's news release announcing the new regulations note that drugs and medical devices are an important part of Canada's health care system, adding that serious adverse drug reactions and medical device incidents are significantly under-reported, both in Canada and internationally.
Ginette Petitpas Taylor, Canada's minister of Health, announced the regulations, saying they will improve the quality and increase the number of reports Health Canada receives on these incidents, allowing the department to better monitor the safety of drugs and devices on the market. The regulations are part of Health Canada's Action Plan on Medical Devices, which was announced in December 2018.