Urgent public health need status for COVID-19 testing applications: Notice to industry

Date published: September 26, 2022

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Background

For a COVID-19 medical device to be authorized for importation or sale under Interim Order (IO) No. 3, the Minister must determine if there is an urgent public health need (UPHN) for that device.

On July 16, 2021, Health Canada published a notice to stakeholders that certain categories of testing devices no longer had UPHN status. As of this date, we were no longer accepting such devices for review under the IO. Devices for which the UPHN status was no longer in effect included testing devices using only nasopharyngeal sample types. More recently, on April 1, 2022, we added other categories of COVID-19 testing devices (for example, serology tests) to this list.

As the pandemic evolves, Health Canada will continue to assess the UPHN status for COVID-19 testing devices. This approach allows us to:

Purpose

This notice is to inform manufacturers, importers and distributors of the upcoming change for additional testing devices that will no longer have UPHN status. This change takes effect on October 26, 2022.

This update only affects COVID-19 Class IV testing device applications.

COVID-19 testing applications

Many authorized COVID-19 testing devices offer a nasal sample type. For this reason, this category of testing devices will no longer have UPHN status.

As of October 26, 2022, only the following 5 categories of testing devices will be accepted under the IO:

  1. testing technologies that offer a multiplex feature for the detecting COVID-19 and other respiratory pathogens (for example, influenza A, B and respiratory syncytial virus)
  2. molecular or antigen tests that offer saliva sample types
  3. testing technologies that offer other unique sample types
  4. testing technologies that offer a unique feature that meets a clinical or accessibility need
  5. testing devices that offer environmentally sustainable features

Applicants must provide direct evidence or scientific justification, in accordance with applicable submission guidance, to support their testing device claims.

Manufacturers of testing devices that are in the process of finalizing their application for submission are encouraged to take advantage of this advance notice to submit your application before October 26, 2022. The following examples provide additional guidance in determining whether your COVID-19 test will be accepted for review under the IO beyond this date.

Examples of COVID-19 testing technologies that will be accepted:
  • molecular or antigen multiplex tests (this could include nasal multiplex tests)
  • molecular or antigen tests that offer saliva sample types
  • molecular or antigen tests that offer nasal sample types as well as address accessibility needs of persons with disabilities or infants (aged 0 to 2 years old)
  • breathalyzer technologies
Examples of COVID-19 testing technologies that will not be accepted:
  • molecular or antigen self tests that only offer a nasal sample type
  • lab-based and point-of-care antigen or molecular tests that only offer a nasal sample type
  • *serology tests (UPHN assessment date: April 1, 2022)

*Health Canada will not accept amendment applications to add point-of-care claims to serology tests that have been authorized under the IO.

We will continue to review applications submitted for review before October 26, 2022 under the IO. However, please note that we will give priority to testing devices that address the current urgent public health need. Our focus will continue to reflect Canadian public health priorities.

Manufacturers may still submit applications to amend their authorized tests. We encourage amendments that add any of the features that address the current urgent public health need.

Health Canada may still accept an IO application for a device that does not fall within the 4 categories. The applicant must provide sufficient evidence there is an urgent public health need within Canada. We will consider the evidence, consult our public health partners when required and inform the applicant of our decision.

The Medical Devices Regulations pathway remains open for obtaining medical device licences for all types of testing devices.

Health Canada will re-assess the status of testing devices from time to time as the pandemic evolves. We will continue to work closely with public health partners and the scientific community to ensure that our priorities reflect the urgent public health need of people living in Canada.

Contact us

If you have any questions, please contact the Medical Devices Directorate by email at devicelicensing-homologationinstruments@hc-sc.gc.ca.

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