Priority COVID-19 test applications: Notice to manufacturers, importers and distributors

Date published: May 7, 2021

On this page

• Purpose and background
• Technologies that are a priority
• Technologies that are not prioritized for review
• Access to testing devices for COVID-19

Purpose and background

Health Canada regulates the sale and import of medical devices, including commercial testing devices related to COVID-19.

As noted elsewhere, Health Canada has made it a priority to review applications for COVID-19 devices that meet an urgent public health need in Canada. These devices are needed immediately to protect or improve the health of Canadians, whether at the individual or community level.

The purpose of this notice is to communicate the types of testing technologies that Health Canada considers are a priority for review.

Only commercial testing devices that we have authorized can be advertised, imported or sold in Canada. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. Authorized COVID-19 tests are well supported by evidence that shows they will provide accurate and reliable results.

Technologies that are a priority

Working with our public health partners, we have identified the following testing technologies as being of the highest priority for evaluation at this time:

• self-testing devices
• point-of-care antigen or molecular testing devices that use nasal swab or saliva samples for use in symptomatic and asymptomatic populations administered by trained operators (rather than health care professionals)
  • asymptomatic populations are people who do not display COVID-19 symptoms at the time of testing (see the guide on COVID-19 signs, symptoms and severity of disease)
  • to add to clinical trial populations, asymptomatic people may include those who have recently had contact with someone diagnosed with COVID-19 (applicants are encouraged to contact us before designing a clinical trial to ensure appropriate populations are included and adequately characterized)

We welcome new applications for these types of tests, as well as applications to amend authorized tests to include these new features.

Applicants should provide direct evidence or scientific justification if appropriate. Scientific justification could include scientific articles on the performance of an applicant's device or highly similar device by trained operators, or in sample asymptomatic populations.

Applicants are invited to consider strategies to strengthen the performance of their device for its claimed indications. Strategies may include:

• serial testing strategies
• paired testing strategies
• clarification of how the intended purpose of the testing device meets specific public health goals

These strategies could likewise be supported by direct evidence or scientific justification, if appropriate.

Other technologies that are a priority include:

• point-of-care antigen tests that do not use only nasopharyngeal (NP) swab samples, or may be used in asymptomatic people or may be administered by trained operators
• point-of-care molecular tests that do not use only NP swab samples, or may be used in asymptomatic people or may be administered by trained operators
• tests designed to address emerging variants
• tests that offer new or unique advantages compared to other tests of the same type
  • this includes tests that feature accessibility functionalities for use by persons with disabilities
• novel diagnostic technologies that may use alternative samples, such as breath, or a different analytical approach

We may review the types of applications or tests that we are prioritizing at any time to ensure our focus continues to reflects Canadian public health priorities.

Technologies that are not prioritized for review

To ensure that the number and types of authorized testing technologies is aligned with the public health need, Health Canada has been prioritizing certain tests. Given the number of tests already authorized, as well as current public health needs, the following testing technologies are now considered to be of less priority:

• lab-based molecular tests that do not use saliva samples or otherwise offer new or unique advantages
• point-of-care antigen or molecular tests that use only NP swab samples
• lab-based and point-of-care serology tests

This means that these files will be advanced as quickly as can be enabled once the priority tests have been addressed. Identifying a file as being of lower priority may occur at any point after we receive an application. Often, when we "deprioritize" a file, it means that we will address such applications while we wait for information from an applicant for a priority test. Thus, it will take us longer to process applications for deprioritized tests than for priority tests.

Access to testing devices for COVID-19

Early diagnosis is critical to slowing and reducing the spread of COVID-19 in Canada. As part of the government's broad response to the pandemic, Health Canada introduced a number of agile regulatory measures to expedite the regulatory review of COVID-19 health products. These measures do not compromise Canada's safety, efficacy and quality standards. We are committed to getting Canadians access to the tools they need to fight the spread of COVID-19 in Canada.

We have authorized a number of COVID-19 tests and continue to expedite the review of testing device submissions. For more information on the authorization process for COVID-19 testing devices, please consult testing devices for COVID-19.