COVID-19 tests are considered medical devices and are regulated under the Medical Devices Regulations in Canada. Medical devices are classified into 4 classes: Class I are those with the lowest risk and Class IV is the highest. COVID-19 tests are classified as Class IV medical devices due to their high risk-of-use. The regulatory requirements for bringing a medical device to Canada differs based on class. Class I medical devices require only a Medical Device Establishment Licence (MDEL), while Class II, III, and IV medical devices require a Medical Device Licence (MDL) and an MDEL. However, in light of the pandemic, Health Canada has issued an Interim Order Authorization regulatory pathway in order to accelerate the review process of MDEL and MDL submissions.
Amid the initial wave of the COVID-19 outbreak, Health Canada created the Interim Order respecting the importation and sale of medical devices for use in relation to COVID (Interim Order No. 1) to expedite the application and approval processes for medical devices with urgent public health needs. Interim Order No. 1 was signed by the Minister of Health on March 18, 2020 and expired on March 01, 2021.
Interim Order No. 2 was issued in March 2021 to replace Interim Order No. 1 and continues to maintain the flexibilities and regulatory oversight of the first one for another 6 months. All COVID-19 devices authorized under Interim Order No. 1 are still valid and can still be imported and sold in Canada. The authorization for importation or sale of medical devices pursuing this regulatory pathway is only valid for the period the interim order is in effect.
Manufacturers are required to submit an application to obtain authorization to sell or import a COVID-19 medical device under Interim Order No. 2. However, as of August 05, 2021, lab-based molecular tests (PCR) that do not offer saliva or other unique sample types, point-of-care antigen and molecular (PCR) tests that can only be used with nasopharyngeal swab samples, and lab-based serology tests are no longer considered as having an urgent public health need status, thus cannot be approved under Interim Order No.2 any longer.
COVID-19 tests authorized under Interim Order are currently in the so-called “transition period”, where these devices would be deemed medical device licences under the Medical Devices Regulations for up to 2 years. A regular medical device licence will be issued if the specific requirements are met and approved by Health Canada. When a regular medical device licence is issued, manufacturers will start paying medical device right-to-sell fees. You can refer to fees for drugs and medical devices order for more details.
For those that submitted applications using the Interim Order Authorization pathway but have not received a decision, Health Canada will continue to review the applications and the approved applications would be issued a transitional medical device licence that is valid for a period up to the end of the 2-year transition period.
Manufacturers who wish to bring their COVID-19 tests to market in Canada need to register the device with Health Canada to obtain a Medical Device Licence (MDL). This is the most common regulatory pathway for commercializing medical devices. An application for a Class IV medical device licence should contain a completed MDL Application Form, a Fee Form, quality plan, information pertaining to the device description, intended use, and design, labelling material, safety and effectiveness studies, and risk assessment.
The completed application package should be sent to devicelicensing-homologationinstruments@hc-sc.gc.ca. The performance standard by Health Canada is 90 calendar days for a Class IV medical device.
For more information, refer to Health Canada’s website on Medical Device Licensing.
Distributors and importers of COVID-19 testing devices only need to obtain a Medical Device Establishment Licence (MDEL) as opposed to the full MDL. This MDEL grants them authorization to import and/or distribute such devices in Canada. However, if you are a manufacturer who intends to sell a COVID-19 testing device in Canada without a distributor or importer, you must obtain your own MDEL regardless of the class of your device. This regulatory pathway requires the completion of the MDEL Application Form (FRM-0292). The completed MDEL application forms, amendments, and/or notifications should be emailed to hc.mdel.application.leim.sc@canada.ca. The turnaround time to issue a decision is 120 calendar days from the day a complete application is received.
For more information, refer to Health Canada’s website on Medical Device Licensing.
If you would like to learn more about the regulations on medical devices or need help becoming compliant, contact us today.