Interim enforcement approach for federal, provincial and territorial COVID-19 testing initiatives

Medical Devices Compliance Program Bulletin, December 13, 2021

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• COVID-19 tests and federal, provincial and territorial initiatives
• Interim enforcement approach

COVID-19 tests and federal, provincial and territorial initiatives

There are currently various technologies to detect SARS CoV-2, the virus that causes COVID-19. Health Canada has authorized three types of tests:

1. molecular (often referred to as a PCR, or polymerase chain reaction, test): detects the SARS-CoV-2 RNA genome
2. antigen: detects the proteins that make up the SARS-CoV-2 virus
3. serology (often referred to as an antibody test): tells if you have antibodies to the SARS-CoV-2 virus
   • antibodies may be developed in response to a previous infection by SARS-CoV-2 virus or in response to vaccination
   • these tests cannot indicate if you have protective immunity

Screening asymptomatic individuals for SARS CoV-2 is proving to be effective in high-risk settings where social distancing and other measures are not feasible.

Through various federal, provincial and territorial COVID-19 testing initiatives, COVID-19 tests are provided to eligible workplaces, organizations, their employees, their clients and individuals. These initiatives will help organizations detect early cases of COVID-19 for people who are asymptomatic.

Interim enforcement approach

When COVID-19 tests are advertised or sold with claims different from their market authorization (label and instructions for use), the advertisement or sale is considered "off-label".

In the interest of public health, Health Canada is not prioritizing the enforcement of off-label sale and advertising of authorized COVID-19 tests where the following conditions are met:

• Tests are provided through a federal, provincial or territorial COVID-19 testing initiative
• Information is provided to participants of these initiatives about the limitations and sensitivity of the COVID-19 test when used off-label, as well as information on nucleic-acid based testing being the gold standard for diagnosing COVID-19
• Administration of the tests follows provincial or territorial guidance (may vary by province/territory)
• For the Federal Worksite Testing Program, testing is administered regularly to employees in accordance with the interim guidance on the use of rapid antigen detection tests for identifying SARS-CoV-2 infection

Additionally, Health Canada will also not prioritize the enforcement of the requirement for participating establishments (such as pharmacies, Chambers of Commerce, and organizations) to hold a Medical Device Establishment Licence, where applicable, when they are distributing COVID-19 tests under the terms and conditions of a federal, provincial or territorial COVID-19 testing initiative. However, as a risk mitigating measure, Health Canada wishes to maintain oversight on the distribution chain of these products in Canada by:

• requesting that federal, provincial and territorial initiatives maintain lists of their respective participating establishments; and
• requesting that participating establishments maintain distribution records, develop processes to respond to complaints, and develop processes to conduct recalls where a health and safety risk is identified.

This enforcement discretion policy will be in effect until March 31, 2022. Health Canada will review this enforcement approach and reserves the right to enforce the Food and Drugs Act, Regulations and Interim Orders if Health Canada identifies actual or potential risks to health and safety.

Related links

• Rapid tests for COVID-19 screening in the workplace
• Testing devices for COVID-19: Antigen testing devices
• Testing devices for COVID-19: Point-of-care and self-testing devices
• Interim guidance on the use of rapid antigen detection tests for the identification of SARS-CoV-2 infection
• Guidance on Medical Device Establishment Licensing (GUI-0016)