Health Canada

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 the symptoms of COVID-19.

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 to check this list regularly for those products no longer authorized.

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 expedite access to COVID-19 medical devices. The following information explains what resources to check to determine if a...

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...

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.

Indicators for easing public health measures

In the context of the ongoing pandemic, NACI recommends extending the time between the first and second dose of COVID-19 vaccines up to four months while vaccine supply is limited.

Since COVID-19 vaccines were first authorized in Canada in December 2020, the National Advisory Committee on Immunization (NACI) has been providing evidence-informed guidance on the recommended interval between vaccine doses.

Health Canada, working with provinces and territories and other partners, has established a Critical Drug Reserve to help bolster Canadas supply of drugs used to treat COVID-19 patients. The reserve will help avoid shortages and support Canadas pandemic response.

The Interim Order (IO) No. 2 continues to support the optional pathway introduced by IO No. 1 to facilitate clinical trials for potential COVID-19 drugs and medical devices.