HC How to get authorization
The Interim Order No. 3 to import and sell medical devices related to COVID-19 allows Health Canada to carry out expedited evaluations of applicable applications. A first interim order was introduced to that effect on March 18, 2020. The second interim order was introduced on March 1, 2021 and replaced the first one. The third interim order was introduced on February 21, 2022 and replaced the second one. This is the most effective pathway for manufacturers wanting to apply for authorization for COVID-19 test devices. As part of the application, manufacturers will be required to explain the safety, effectiveness and quality of their medical device. We are waiving the fees for these applications.
Submission requirements
Manufacturers must ensure that performance claims are supported by studies carried out:
- for the intended users
- in the intended setting and
- under the intended conditions of use
For tests designed for point of care or self-testing, this means conducting a study to demonstrate that users can use the device safely and effectively according to the instructions for use.
Health Canada refers to guidance published by the U.S. Food and Drug Administration (FDA) for point-of-care testing and self-testing kits. This guidance may be an addendum to requirements established for molecular and/or antigen-based tests. Please review our instructions related to these technologies to ensure your application is complete.
For point-of-care indications:
For self-testing indications:
Health Canada expects manufacturers following the FDA guidance for molecular and antigen tests for non-laboratory use to follow the guidance provided for non-prescription testing. This is because the distinction made by the FDA between prescription and non-prescription testing doesn’t exist in Canada.
The FDA guidances are in a template format and outline requirements that these products must meet.
For more information on Health Canada’s standard guidance for each of these specific technologies, please consult their respective pages.
To submit an application for authorization, follow these 4 steps:
- Review the guidance document on how to apply for medical devices for use in relation to COVID-19, under the interim order.
- Review the relevant requirements for near patient IVDDs as outlined above.
- Prepare your submission package. Each submission must include enough information, including relevant test data and device labelling, so that Health Canada can authorize the device.
- Submit your application to the Medical Devices Directorate at devicelicensing-homologationinstruments@hc-sc.gc.ca.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.