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The purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.

Under the Interim Order, manufacturers and importers must report medical device shortages related to COVID-19 to Health Canada. The devices to which the shortages apply are on the List of Medical Devices — Notification of Shortages (specified medical devices).

COVID-19 is a new disease not previously identified in humans. Health Canada is closely tracking all potential drugs and vaccines in development in Canada and abroad. We are working with companies, academic research centres and investigators to help expedite the development and availability of...

The COVID-19 pandemic is adding to the ongoing public health crisis related to high rates of opioid overdose and deaths, as well as acute substance use harms. These crises are made worse in communities where there is chronic overcrowding, including a shortage of housing or other shelters.

Health Canada (HC) and the Canadian Institutes of Health Research (CIHR), with the collaboration and participation of the Canadian Association of Research Ethics Boards (CAREB), recognize the urgent need to conduct clinical trials to evaluate the safety and efficacy of a drug, a vaccine or a...

This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.

Most PPE, including face shields, are Class I medical devices if they are manufactured, sold or represented for use for reducing the risk of or preventing the user from infection. This includes COVID-19. Face shields may be authorized for sale or import into Canada through the following 3...

This document provides guidance for Canadian manufacturers on the minimum technical requirements for facepiece filtering respirators (FFR). Health Canada has also published a guidance document to assist manufacturers in preparing applications submitted under the IO. This guidance document should...

This document provides care guidance specific to the COVID-19 pandemic in Canadian homes/facilities where older adults require continuous supervised care, including professional health services, personal care and other services such as meals, laundry and housekeeping.

As provinces and territories lift or adjust public health measures, we have to think about the risks associated with different settings and activities. Before going out, consider the risks and make informed choices to keep yourself, your family and your communities safe. If a planned activity...