On 15thJune, Health Canada published a consultation proposing amendments to the Food and Drugs Regulations and Medical Device Regulations requiring hospitals to report serious adverse drug reactions and medical device incidents.
Incidents are to be reported to Health Canada in writing within 30 days. It would only apply to hospitals, whereby only ‘serious’ incidents involving drugs are reported. There are no restrictions on medical device incidents.
Stakeholders have been invited to provide comments on the proposal by 29thAugust 2018.