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Catalogue Entry: Medical devices: Diagnostic devices for use against coronavirus (COVID-19)
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...-
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Catalogue Entry: Resources for Canadians living with pain during COVID-19: Resources
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...-
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Catalogue Entry: Conducting a clinical trial for COVID-19 medical devices: List of authorized...
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.-
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Catalogue Entry: Collaboration with the Public Health Agency of Canada’s National Microbiology Lab
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...-
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Catalogue Entry: Safety and performance specifications for respirators during COVID-19:...
This document provides guidance for Canadian manufacturers on the minimum technical requirements for facepiece filtering respirators (FFR). Health Canada has also published a...-
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Catalogue Entry: Regulatory considerations for importing or selling face shields: Notice to industry
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...-
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Catalogue Entry: Testing devices for COVID-19: Test swabs safety and effectiveness guidance
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...-
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Catalogue Entry: Joint Statement on Clinical Trial Oversight in Canada
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),...-
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Catalogue Entry: Helping people who use substances during the COVID-19 pandemic
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...-
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Catalogue Entry: Health product advertising incidents related to COVID-19
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...-
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Catalogue Entry: COVID-19 guidance for reporting medical device shortages: Background
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...-
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Catalogue Entry: Testing devices for COVID-19: Antigen testing devices
The purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.-
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Catalogue Entry: Drug and vaccine authorizations for COVID-19: Overview
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...-
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Catalogue Entry: Joint Statement on Clinical Trial Oversight in Canada
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),...-
File available for download in the following formats:
- HTML
-
Catalogue Entry: Helping people who use substances during the COVID-19 pandemic
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...-
File available for download in the following formats:
- HTML
-
Catalogue Entry: Health product advertising incidents related to COVID-19
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...-
File available for download in the following formats:
- HTML
-
Catalogue Entry: Safety and performance specifications for respirators during COVID-19:...
This document provides guidance for Canadian manufacturers on the minimum technical requirements for facepiece filtering respirators (FFR). Health Canada has also published a...-
File available for download in the following formats:
- HTML
-
Catalogue Entry: Regulatory considerations for importing or selling face shields: Notice to industry
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...-
File available for download in the following formats:
- HTML
-
Catalogue Entry: Testing devices for COVID-19: Test swabs safety and effectiveness guidance
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...-
File available for download in the following formats:
- HTML
-
Catalogue Entry: COVID-19 guidance for reporting medical device shortages: Background
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...-
File available for download in the following formats:
- HTML