- by Health CanadaHealth Canada's Regulatory Operations and Enforcement Branch revised the guidance on regulatory requirements in relation to the medical device establishment licence (MDEL).
- by Health CanadaMonthly summary of serious adverse drug reactions and medical device incidents reported by Canadian hospitals
- by Health CanadaHealth Canada wants your feedback on the draft Guidance for determining medical device application type.
- by Health CanadaGuidance on the Amendments to the Food and Drugs Act: Guide to New Authorities was developed to help Health Canada implement the new authorities that came into force upon royal assent of Bill C-17, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
- by Health CanadaGuidance document outlining policy and procedure surrounding machine learning-enabled medical devices
- by Health CanadaThe Medical Devices Licence Amendment Minor Change Form for changes to manufacturer’s name and/or address has been updated to include references to COVID-19 authorizations.
- by Health CanadaInformation on infant incubators (including infant transport incubators) and radiant warmers and the potential risks surrounding falls from them.
- by Health CanadaInformation about the types of patient lifts (also called hoists), how to manage the risk of falls, and reporting a serious adverse event.
- by Health CanadaThe Medical Devices Directorate quarterly performance report for Q4 2022-23 provides detailed metrics about the timeliness of pre-market medical devices review process against the performance service standards.
- by Health CanadaHealth Canada is seeking input from health care, industry, and other stakeholders about improving access to drugs and other health products for people in Canada to enhance the collective response to drug and other health product shortages. We are seeking your feedback on four key areas for action related to preventing shortages and better mitigating their impacts.
- by Health CanadaHealth Canada is proposing to amend the Medical Devices Regulations and the Food and Drug Regulations to modernize the frameworks for establishment licences and recalls.
- by Health CanadaVoluntary use of the Regulatory Enrolment Process (REP) for medical devices as of January 2024.
- by Health CanadaNotice on Health Canada's proposed regulatory amendments to expand the Medical Devices Regulations beyond COVID-19 medical devices.
- by Health CanadaHealth Canada is seeking feedback on proposed changes to the Medical Devices Regulations as well as feedback on the implications they may have on fees.