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Catalogue Entry: Testing devices for COVID-19: Overview
As the pandemic evolves, we are continuously updating our guidance and positions in light of the new scientific information available to us. We are open to reviewing all testing...-
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Catalogue Entry: Testing devices for COVID-19: Point-of-care and self-testing devices
A near patient in vitro diagnostic device (IVDD) is used for: point-of-care testing in a health care setting (for example, doctor’s office, pharmacy, at the bedside) or self-...-
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Catalogue Entry: Testing devices for COVID-19: Nucleic acid testing devices
Nucleic acid-based testing is also called molecular testing, and is often called PCR. Molecular tests detect the virus genetic material (nucleic acids). Public health...-
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Catalogue Entry: Ventilators for patients with COVID-19
Ventilators are an important piece of medical equipment in the fight against COVID-19, the disease caused by the novel coronavirus. Health care professionals use ventilators to...-
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Catalogue Entry: Important regulatory considerations for the supply of medical gowns:...
The purpose of this document is to provide regulatory information with regard to medical gowns.-
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Catalogue Entry: Notice: Technical requirements for anti-microbial claims for medical masks
This notice outlines the safety and effectiveness requirements for Class I medical masks and face coverings with anti-microbial claims. This notice is for manufacturers using...-
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Catalogue Entry: Health Canada’s regulatory response to COVID-19: International engagement
International collaboration ensures that our policies and regulatory approaches are aligned and that health products are effective and made available to Canadians quickly.-
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Catalogue Entry: Health Canada’s regulatory response to COVID-19: Access to health products
As part of the government's broad response to the pandemic, Health Canada introduced innovative and agile regulatory measures. These measures expedite the regulatory review of...-
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Catalogue Entry: Testing devices for COVID-19: Serological testing devices
Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Serology tests are also known as antibody tests....-
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Catalogue Entry: Medical devices for COVID-19: Conducting a clinical trial
Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing...-
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Catalogue Entry: Guidance on safety and performance specifications for filtering facepiece...
The Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 on March 18, 2020. A second Interim Order...-
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Catalogue Entry: Medical devices for COVID-19: Conducting a clinical trial
Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing...-
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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. Authorization is done through the Medical Device Regulations or the...-
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Catalogue Entry: Conducting a COVID-19 drug and vaccine clinical trial
Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process...-
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Catalogue Entry: Authorized medical devices for uses related to COVID-19: Overview
In addition to existing medical device databases, there are lists of authorized COVID-19-related medical devices. These lists are a result of regulatory tools in place to...-
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Catalogue Entry: Authorized medical devices for uses related to COVID-19: List of products no...
Authorizations may be revoked for some medical devices that were authorized under either the: IO No.1 or IO No. 2. It is important for health care professionals and other users...-
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Catalogue Entry: COVID-19 Treatments
Several different types of treatments for COVID-19 have been developed. Examples include drugs that reduce or stop the virus from multiplying in human cells and drugs that treat...-
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Catalogue Entry: COVID-19 Food labelling support measures
The Government of Canada is working to respond to challenges raised by the food industry as a result of the COVID-19 pandemic while continuing to ensure that Canadians have...-
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Catalogue Entry: Coronavirus disease (COVID-19) and food safety
Learn about food safety during the coronavirus disease (COVID-19) pandemic and how to keep you and your family safe.-
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Catalogue Entry: Interim guide on isopropyl alcohol for use in alcohol-based hand sanitizers...
Companies that use unacceptable quality standards may be subject to enforcement action. Our main goal is to protect the health and safety of the public.-
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