Mandatory use of Regulatory Enrolment Process (REP) for medical device applicationscanada📅 key dates
Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devicescanada📋 regulatory changes
Consultation on draft guidance for determining medical device application typecanada💬 consultations
Consultation on proposed changes to the Medical Devices Regulations to address future public health emergenciescanada💬 consultations
Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canadacanada📋 regulatory changes
Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devicescanada📋 regulatory changes
Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages)canada📋 regulatory changes
Predetermined change control plans for machine learning-enabled medical devices: Guiding principlescanada📋 regulatory changes
Share your views: Consultation on the draft guidance on managing applications for medical device licencescanada💬 consultations
Share your views: Draft Pre-market guidance for machine learning-enabled medical devicescanada💬 consultations
Share your views: Updates made to list of recognized standards for medical devices and draft guidancecanada💬 consultations
Transparency for machine learning-enabled medical devices: Guiding principlescanada📋 regulatory changes
Updates to the medical device establishment licence application (FRM-0292) and instructionscanada📋 regulatory changes