Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices

March 18, 2020 Ottawa, ON Health Canada

Early diagnosis and isolation of patients infected with COVID-19 are essential to slowing the spread of the novel coronavirus across Canada. Since the symptoms of COVID-19 are similar to those of a cold or flu, diagnostic testing is important for clinical care and public health management.

To assist with Canada's response to COVID-19, the Honourable Patty Hajdu, Minister of Health, announced that she has signed an Interim Order to allow expedited access to COVID-19-related medical devices for use by healthcare providers, including diagnostic test kits.

The need for test kits is growing as the number of COVID-19 cases increases across Canada.

This Interim Order will help ensure quicker and more flexible approval of the importation and sale of medical devices that are necessary for Canada's response to COVID-19, including test kits. With the Interim Order, two new diagnostic tests are made readily accessible in Canada:

• the Roche Molecular Systems Inc. cobas SARS-CoV-2 diagnostic device; and
• the ThermoFisher Scientific TaqPath™ COVID-19 Combo Kit

This Interim Order may also help ensure Canadian access to other marketed COVID-19-related medical devices used to treat, mitigate or prevent COVID-19, as necessary.

With this Interim Order, Health Canada could also look to approvals granted by foreign regulatory authorities in deciding whether to approve an application for the importation or sale of COVID-19-related medical devices. Existing devices, where the approved, intended use was not originally COVID-19-related, could also be expanded under this Interim Order.

An Interim Order is one of the fastest mechanisms available to the Government of Canada to help make health products available to address larger scale public health emergencies. This Interim Order provides the Minister with the flexibility to consider the urgent circumstances relating to the need for the medical device, authorizations granted by foreign regulatory authorities, or possible new uses for medical devices that are approved in Canada.

As with all drugs and medical devices, Health Canada will assess and monitor the safety and effectiveness of the devices accessed under this Interim Order once they are on the market, and will take immediate action to protect the health and safety of Canadians if necessary.