Health Canada

Coronavirus, COVID-19, pandemic, outbreak, testing, diagnosis, contact tracing, testing devices, point-of-care, POC, antigen, antibodies, molecular, FDA, non-laboratory use

the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. An IO is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory...

The tables below list the COVID-19-related clinical trials which have been authorized by Health Canada through the Food and Drug Regulations or the Interim order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. IO No. 2 extends and modifies certain measures for drugs that were in the first interim order. An IO is one of the fastest mechanisms available...

How Health Canada is addressing clinical trials of drugs and vaccines, its expedited review process and the Special Access Program to find therapies to prevent or treat COVID-19.

The purpose of this notice is to advise stakeholders that Health Canada is proposing to: maintain the flexibilities and regulatory oversight provided by the Interim order respecting clinical trials for medical devices and drugs relating to COVID-19 until at least the fall of 2021, and bring...

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

This Points to Consider document lays out a regulatory approach for updating authorised coronavirus vaccines should mutations at any time make them less efficacious due to insufficient cross-reactivity.

Learn about food safety during the coronavirus disease (COVID-19) pandemic and how to keep you and your family safe.

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 access to safe and nutritious food.

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 outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

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 Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

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 outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical...

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 was introduced on March 1, 2021 and replaced the first one. The Interim Order (IO) expedites the authorization of Class...

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 outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical...

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. Serological tests are not appropriate for diagnosing COVID-19. However, Health Canada is authorizing the sale in Canada of...

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 COVID-19 health products without compromising safety, efficacy and quality standards.

International collaboration ensures that our policies and regulatory approaches are aligned and that health products are effective and made available to Canadians quickly.

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 give respiratory help to patients who need it. Health Canada reviews all 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 (nucleic acids). Public health laboratories in Canada and around the world use nucleic acid-based testing to diagnose COVID-19 infection. This test is the gold...