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Application Information In Canada, manufacturers must receive a medical device licence for certain health products defined as a "device" under the Food and Drugs Act before they can be sold on the Canadian market. To determine which devices need a licence, all medical devices…

Activities The Therapeutic Products Directorate (TPD) undertakes a variety of activities including the making of policies or regulations to support its role as the federal regulatory authority for the sale of pharmaceutical drugs and medical devices in Canada. These activities…

Notice: Update: Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options December 13, 2019 Our file number: 19-122746-266 Through its Action Plan on Medical Devices ,…

Medical devices contained in electronic health record (EHR) products: Notice to industry This notice is for manufacturers of EHR software products and EHR-based medical devices. Through this notice, Health Canada wants to remind manufacturers of their regulatory obligations for…

Summary reporting provisions of the Medical Devices Regulations: Notice to industry On this page Background and purpose Regulatory flexibility Background and purpose The amended Medical Device Regulations (regulations) that describe summary reporting provisions have been in…

What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023 MDEL Bulletin December 02, 2022, from the Medical Devices Compliance Program On this page About the annual licence review Changes in the package Fees Small business…

Pulse oximeters: Overview Overview For consumers For health care providers Health Canada’s role Pulse oximeters are usually a small unit with a built-in clip that’s placed on the fingertip. Other types have a clip or wire probe with adhesive that’s applied to the ear, foot, hand,…

Health Canada and FDA eSTAR pilot: Notice to industry The Health Canada and U.S. Food and Drug Administration's joint eSTAR pilot is now full, having reached its total of 9 participants. The joint pilot will test the use of a single eSTAR submitted to both the FDA and Health…

Tubed medical devices and children On this page Types of medical devices with tubing Risk of medical devices with tubing Managing the risk Reporting a serious adverse event Medical tubing is used extensively to deliver therapy (nutrition, oxygen or medical substances) to children…

Proposed changes to the Medical Devices Regulations to address future public health emergencies: Notice Date published: March 23, 2023 Health Canada is proposing regulatory amendments to the Medical Devices Regulations (MDR). We're proposing to expand the current provisions under…