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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...

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-testing ( for example, used by individuals at home). Typically, these rapid test devices are simple to use and provide...

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 solutions as they become available.