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

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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:

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:

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.

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