Health Canada

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).

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...

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...

Health Canada scientific reviewers evaluate data to assess the potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product. After the review, we may authorize the drug or vaccine for sale in...

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...

The Public Health Agency of Canada’s National Microbiology Lab (PHAC-NML) will conduct independent scientific laboratory evaluation of some COVID-19 testing devices when requested by Health Canada.

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

The Government of Canada and the Canadian Pain Task Force (CPTF) recognize Canadians living with chronic pain need additional supports during COVID-19. The following list of supportive resources was assembled in collaboration with stakeholders and may be used by you and your partners in care to...

COVID-19 is a new disease. A vaccine or therapy to treat or prevent this disease has not yet been developed. However, the COVID-19 pandemic has resulted in a global review of therapies that may be used to treat or prevent the disease. Canada is speeding up the importation and sale of medical...