Health Canada has recently released an Interim Order (IO) for the importation and sale of Class-IV medical devices used to diagnose, treat, or prevent COVID-19.
**note: An interim order is a mechanism that can help address public health emergencies in the quickest way possible.
Types of devices being accepted for review by Health Canada:
- Nucleic acid amplification testing (NAAT): as per the World Health Organization, “routine confirmation of cases of COVID-19 is based on the detection of unique sequences of virus RNA by NAAT such as reverse transcription polymerase chain reaction (rRT-PCR)” (WHO pdf). As such, diagnostic tests using nucleic acid technology are being prioritized for review to increase the number of tests available in Canada to detect active infections of COVID-19.
- Serological tests: These tests are being accepted for review as well however research into the use of serological testing is ongoing. These tests do not screen for the virus itself, however, they do screen for the antibodies. The WHO does not recommend these for clinical diagnosis as it takes days to weeks for antibodies to active in the bloodstream after infection and also because they remain present in the bloodstream after recovery from infection.
Expedited pathways available under the IO:
- New medical devices not yet licensed in Canada or other jurisdictions
- Existing devices licensed under the Medical Device Regulations or under this IO
- Existing devices with regulatory approval from a trusted foreign regulatory authority
How to get authorization using the IO pathway:
Most medical device authorizations are subject to the following (with the exception of devices approved by a foreign regulatory authority):
- Submit an abbreviated application to support the safety, effectiveness, and quality of your medical device, as per the guidance document (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/interim-order-importation-sale-medical-devices-covid-19/guidance-medical-device-applications.html#a25). Fees for submission are currently being waived. Also, you will not be required to hold a Medical Device Single Audit Programme (MDSAP) certification
- Submit your application directly to the Medical Devices Directorate: firstname.lastname@example.org
Exception: applicants holding market approval for a medical device from a foreign regulatory authority can omit quality, safety and effectiveness information 4(1)(g), as well as materials 4(2)(a), and marketing history 4(2)(b) from their applications.
Products authorized under the IO pathway will still be required to follow post-market safety requirements such as mandatory problem reporting, recall procedures, and complaint handling. Health Canada will also continue monitoring the safety and effectiveness of all products authorized under the IO and will take any actions necessary to protect the health and safety of Canadians.
Please reference the official guidance document here.
For more information regarding this article or any other regulatory matters, please contact dicentra.