COVID-19 medical masks and respirators: How to get authorization

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Expedited access to medical masks and respirators

There is an unprecedented demand and urgent need for access to medical devices during the COVID-19 pandemic. New mechanisms are in place to enable expedited access to medical devices, including two interim orders signed by the Minister of Health to speed up the review of these medical devices and to allow certain medical devices that may not fully meet regulatory requirements to be imported and sold in Canada when they are made according to comparable standards. The use of interim orders 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.

Important information about KN95 medical respirators

The United States Food and Drug Administration (FDA) issued a revised guidance on May 7, 2020. The revised guidance indicates that certain filtering face-piece respirators, including KN95 medical respirators, from China may not provide adequate respiratory protection. Learn more about the new guidance .

Health Canada will continue to encourage manufacturers to seek authorization of KN95 medical respirators in Canada through the Medical Device Interim Order Authorization pathway. As of May 7, 2020, Health Canada will request test results from accredited testing facilities to validate the effectiveness of these respirators.

Authorization pathways for medical masks and respirators

Medical masks and respirators:

There are multiple authorization pathways, depending on who is bringing the product to market (manufacturer, importer or distributor) and other considerations.

Applicants should carefully review the pathways to select the most appropriate authorization route for their product.

Pathway 1: Interim Order Authorizations for the sale and importation of medical devices related to COVID-19

The Interim Order (IO) Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 allows Health Canada to issue expedited authorization for the sale or import of medical devices related to COVID-19. 

Important information about the Interim Order Authorization pathway:

To submit an application for authorization under the IO, follow these steps:

  1. Review the guidance document on how to apply for medical devices for use in relation to COVID-19, under the IO.
  2. Prepare your submission package. Each IO submission must include a copy of the device label and appropriate supporting documentation to demonstrate that the medical mask or respirator meets the specifications published online. Note: As of May 7, 2020, Health Canada will request test results from accredited testing facilities to validate the effectiveness of KN95 medical respirators.
  3. Submit your application to the Medical Devices Directorate at hc.devicelicensing-homologationinstruments.sc@canada.ca.

For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.

Pathway 2: Expedited review and issuance of Medical Device Establishment Licences related to COVID-19

Health Canada is expediting the review and issuance of Medical Device Establishment Licences (MDELs) for companies requesting to manufacture, import or distribute medical devices in relation to COVID-19.

Important information about Medical Device Establishment Licences (MDELs):

To submit an MDEL application for expedited review, follow these steps:

  1. Review the Guidance on Medical device establishment licensing.
  2. Complete the MDEL application form (FRM-0292)
  3. Email the completed MDEL application form to hc.mdel.application.leim.sc@canada.ca, indicating the following in the subject line of the email: URGENT – COVID-19 – MDEL application for ­[name of company]

For any questions related to the MDEL process, please email hc.mdel.questions.leim.sc@canada.ca.

Pathway 3: Exceptional importation and sale of certain masks and respirators that may not fully meet Canadian regulatory requirements

The Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 which allows for the exceptional importation and sale of certain medical devices that may not fully meet regulatory requirements, but are made to comparable standards.

For example, this could include medical masks and respirators that may be past their expiry date, or those that have non-compliant labelling.

Important information about the exceptional importation and sale pathway:

To submit an application for exceptional importation or sale, manufacturers and importers should:

  1. Complete the Medical devices for exceptional importation and sale request form
  2. Email the completed form, along with a copy of the product label to hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca

Health Canada will review the request and inform you of our decision to add the medical device to the List of Medical Devices for Exceptional Importation and Sale.

Once a medical device is on the list:

  1. Importers must notify Health Canada at least 5 calendar days before the designated device is imported, by completing the Exceptional importation and sale notification form.
  2. Notifications should be sent to: hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca

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