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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.
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Closed consultation: Proposed changes to the Medical Devices Regulations to address future public health emergencies Current status: Closed This consultation ran from March 23, 2023, and closed on April 13, 2023. On this page Who was the focus of this consultation Key items for…
Patient lifts and risk of fall On this page Types of patient lifts How to manage the risk of falls Reporting a serious adverse event Types of patient lifts In Canada, all patient lifts are Class 1 medical devices. Class 1 devices present the lowest risk to health and safety.…
Potential risk of falls from infant incubators and radiant warmers On this page Infant incubators and radiant warmers Risk of falls Managing the risk Reporting events Infant incubators and radiant warmers Infant incubators (including infant transport incubators) and radiant…
Share your views: Consultation on draft guidance for determining medical device application type From: Health Canada Current status: Closed This consultation ran from September 11, 2023, and closed on November 10, 2023. Health Canada asked for feedback on the draft Guidance for…
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles On this page Background Guiding principles Contact us Background In 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the U.K.'s Medicines and Healthcare…
Updates to the medical device establishment licence application (FRM-0292) and instructions MDEL Bulletin December 4, 2023, from the Medical Devices Compliance Program On this page Background Key changes in the application Contact us Background On December 4, 2023, Health…
Medical masks and respirators: Overview Overview Information for manufacturers Information for users Health Canada’s role Report a problem or concern Contact us Learn about the many different types of masks and respirators and their use. On this page About masks About respirators…
Transparency for machine learning-enabled medical devices: Guiding principles On this page Background The guiding principles Contact us Background In 2021, Health Canada, the U.S. Food and Drug Administration ( FDA ) and the United Kingdom’s Medicines and Healthcare products…
Updates made to list of recognized standards for medical devices and draft guidance: Closed consultation From Health Canada Current status: Closed This consultation ran from July 25 to September 23, 2024. Health Canada consulted stakeholders on updates we made to the: List of…
Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices On this page About the updates About the consultation Contact us About the updates Health Canada has updated the: List of recognized standards for medical devices and Guidance…
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