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Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Serology …

Record Modified: Jun 30, 2021
Record Released: Jun 30, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic testing devices testing devices for COVID-19 Serological testing devices antibodies antibody tests detection of antibodies

As part of the government's broad response to the pandemic, Health Canada introduced innovative and agile regulatory measures. These measures …

Record Modified: Jun 30, 2021
Record Released: Jun 30, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic Health Canada’s regulatory response regulatory measures expedite the regulatory review access to health products

International collaboration ensures that our policies and regulatory approaches are aligned and that health products are effective and made available …

Record Modified: Jun 30, 2021
Record Released: Jun 30, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic Health Canada’s regulatory response access to health products international engagement

This notice outlines the safety and effectiveness requirements for Class I medical masks and face coverings with anti-microbial claims. This …

Record Modified: Jun 30, 2021
Record Released: Jun 30, 2021
Publisher: Health Canada
Formats: HTML
Keywords: technical requirements technical requirements for anti-microbial claims medical masks safety and effectiveness requirements Class I medical masks face coverings

The purpose of this document is to provide regulatory information with regard to medical gowns.

Record Modified: Jun 30, 2021
Record Released: Jun 30, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance to industry regulatory considerations supply of medical gowns

Ventilators are an important piece of medical equipment in the fight against COVID-19, the disease caused by the novel coronavirus. …

Record Modified: Jun 30, 2021
Record Released: Jun 30, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic ventilators ventilators for patients with COVID-19 respiratory help to patients COVID-19-related submissions and applications

Nucleic acid-based testing is also called molecular testing, and is often called PCR. Molecular tests detect the virus genetic material …

Record Modified: Jun 29, 2021
Record Released: Jun 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic testing devices testing devices for COVID-19 nucleic acid testing devices molecular testing PCR nucleic acid-based testing COVID-19 infection gold standard to diagnose COVID-19 infection

A near patient in vitro diagnostic device (IVDD) is used for: point-of-care testing in a health care setting (for example, …

Record Modified: Jun 29, 2021
Record Released: Jun 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic testing devices testing devices for COVID-19 point-of-care and self-testing devices rapid tests

As the pandemic evolves, we are continuously updating our guidance and positions in light of the new scientific information available …

Record Modified: Jun 29, 2021
Record Released: Jun 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic testing devices testing devices for COVID-19 testing solutions

In November 2020, the Minister of Health established the COVID-19 Testing and Screening Expert Advisory Panel. The Panel provides evidence-informed …

Record Modified: Jun 29, 2021
Record Released: Jun 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Optimize testing and quarantine at Canada’s borders COVID-19 Testing and Screening Expert Advisory Panel advice to the federal government on science and policy related to testing and screening recommendations for land and air border measures