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

OTTAWA, March 18, 2020 /CNW/ - 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.

Quotes

"COVID-19 is a rapidly evolving global health crisis, and we have been working around the clock with provinces and territories to make sure everyone has what they need to continue to detect and interrupt the chain of transmission. Early diagnosis is a critical component, so we are taking extraordinary measures to help make that happen as quickly as possible."
The Honourable Patty Hajdu
Minister of Health

Quick Facts

• Health Canada has now authorized the sale and importation of two new diagnostic test kits:
• the Roche Molecular Systems Inc. cobas SARS-CoV-2 diagnostic device; and
• the ThermoFisher Scientific TaqPath™ COVID-19 Combo Kit
• Interim Orders remain in effect for 14 days, and can be extended for up to one year by the Governor in Council, after which they may be renewed if required.
• Before the introduction of the Interim Order, Health Canada enabled access to diagnostic test kits via the Special Access Program (SAP).
• Canadians who experience symptoms of COVID-19 should stay home and call the public health authority in their province or territory to inform them and obtain advice on what they should do.

Associated Links

Interim Order Notice 
Coronavirus disease (COVID-19): Canada's response

SOURCE Health Canada