Health Canada Expedites Access to COVID-19 Diagnostic Laboratory Test Kits and Other Medical Devices
Recently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices for use by healthcare providers, including diagnostic test kits. This Interim Order will help ensure quicker and more flexible approval of the importation and sale of medical devices that are necessary for Canada’s response to COVID-19.
Nucleic acid amplification testing is the diagnostic technology used by public health laboratories across Canada and around the world for diagnosis of COVID-19 infection. 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.
Devices using serological technology are also being accepted for review. However, this type of testing is not currently recommended by the World Health Organization as it does not detect the virus itself. Instead, they detect the antibodies produced in response to an infection which can delay the detection from days to weeks.
The expedited authorization pathways under the Interim Order applies to new COVID-19-medical devices that are not yet licensed in Canada or other jurisdictions, existing COVID-19-medical devices licensed in Canada expanding its indication for use to include COVID-19-related uses and existing COVID-19 medical devices that have obtained authorization from a trusted foreign regulatory authority
For Expedited Review Process, manufacturers are required to submit an abbreviated application to support the safety, effectiveness, and quality of their medical devices. Manufacturers applying through this pathway will not be required to hold a Medical Device Single Audit Programme (MDSAP) certification.
Manufacturers will still be required to follow strict post-market safety requirements such as mandatory problem reporting, recall procedures, and complaint handling.
As with all drugs and medical devices, Health Canada will continue to assess and monitor the safety and effectiveness of all products authorized under the Interim Order and will take immediate action if required to protect the health and safety of Canadians. If you or your company is looking to market your COVID-19-related medical devices in Canada, now is the time act.
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