Ventilators for patients with COVID-19
Only ventilators authorized or licensed in Canada have been evaluated by Health Canada for safety and effectiveness. Users should be aware that unauthorized and unlicensed devices may not perform as intended.
Ventilators are an important piece of medical equipment in the fight against COVID-19, the disease caused by the novel coronavirus. Health care professionals use ventilators to give respiratory help to patients who need it.
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Canada is speeding up the importation and sale of medical devices used to diagnose, treat or prevent COVID-19. On March 18, 2020, the Minister of Health approved an interim order (IO) to speed up the review of these medical devices, including ventilators. An IO is one of the fastest ways to respond to large-scale public health emergencies.
Health Canada reviews all COVID-19-related submissions and applications as quickly as possible without compromising patient safety.
How to get authorization
Under the IO, manufacturers submit an application that explains the safety, effectiveness and quality of their medical device. We are waiving the fees for these applications.
We have developed a guidance document to help manufacturers and importers apply to sell and import medical devices under the IO for use during the COVID-19 pandemic.
As well, Health Canada's notice on the importation or sale of ventilators gives important information that is needed to apply for ventilator authorization. The notice gives key information on:
- IO submission requirements
- how Health Canada reviews these devices and the US FDA's guidance on ventilators
- a list of Canadian manufacturers that offer ventilator details to begin production
To submit an application for authorization under the IO, follow these steps:
- Review the guidance document on how to apply for medical devices for use in relation to COVID-19, under the IO.
- Prepare your submission package. Each IO submission must include enough information, including device labelling, so that Health Canada can authorize the device. Manufacturers are strongly encouraged to review the notice before submitting the application.
- Submit your application to the Medical Devices Directorate at firstname.lastname@example.org.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at email@example.com.
List of ventilators authorized under the interim order
Medical devices authorized through the IO, including ventilators, are posted in the list of products authorized under the IO.
- Notice: Importation or sale of ventilators - use of US FDA guidance and Canadian requirements for authorization under the Interim Order
- Applications for medical devices under the Interim Order for use in relation to COVID-19
- Interim order respecting the importation and sale of medical devices for use in relation to COVID-19
- Medical devices for use against coronavirus (COVID-19): List of products authorized under Interim Order
- Notice: Expedited review of health product submissions and applications to address COVID-19
- Notice for industry: Mandatory reporting requirement during the COVID-19 pandemic
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