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

On this page

• Expedited access to medical masks and respirators
• Important information about KN95 medical respirators
• Authorization pathways for medical masks and respirators

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 2 interim orders signed by the Minister of Health to:

• speed up the review of these medical devices and
• 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:

• are Class I medical devices
• require authorization from Health Canada prior to importation or sale

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

Interim Order No. 3 (IO No. 3) 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:

• This pathway is for manufacturers of all classes of devices, including Class I devices such as masks and respirators (including KN95) that are not approved in Canada and are needed in relation to COVID-19.
• Manufacturers submit an abbreviated application to support the safety, effectiveness and quality of their medical device.
• Health Canada will conduct a scientific review before authorizing the sale of these devices.
• No fees apply to this pathway.
• Manufacturers that receive an authorization for Class I devices under IO No. 3 are not required to obtain a Medical Device Establishment Licence (MDEL).
• The application covers a single medical device product. Separate authorizations under IO No. 3 are required for each product.
• Medical devices authorized under IO No. 3 are posted in the list of products authorized under the interim order.
• Importers and distributors are required to hold a medical device establishment licence (MDEL) and manufacturers must comply with bilingual labelling requirements. See the guidance document for Interim Order No. 3 for relevant information.

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 IO No. 3.
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 devicelicensing-homologationinstruments@hc-sc.gc.ca.

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

• Manufacturers, importers and distributors of Class I medical masks and respirators must have an MDEL before they can import or sell in Canada. The exceptions to holding an MDEL related to medical masks and respirators include:
  • manufacturers that have been granted authorization under Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19
  • manufacturers of medical masks or respirators that import or distribute solely through a person that holds a MDEL
  • retailers and health care facilities, as they do not need an MDEL
• A completed MDEL application form is required.
• The fee to apply is $4,590, but the MDEL holder may qualify for a fee mitigation.
• MDEL holders can be authorized to sell, import or distribute multiple types of medical devices under one licence.

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 Second 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:

• Medical devices included on the List of Medical Devices for Exceptional Importation and Sale are called "designated medical devices" and are eligible for exceptional importation and sale under the Interim Order.
• Manufacturers or importers must have a Medical Device Establishment Licence (MDEL) or Medical Device Licence (MDL) to use 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 medicaldevices.covid19.instrumentsmedicaux@hc-sc.gc.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: medicaldevices.covid19.instrumentsmedicaux@hc-sc.gc.ca

Related links

• List of KN95s that were tested by NIOSH
• FDA - Certain filtering facepiece respirators from China may not provide adequate respiratory protection (letter to health care providers)
• Fraudulent and unauthorized N95 respirators may not protect consumers against COVID-19
• Notice – Important regulatory considerations for the reprocessing of single-use N95 respirators during the COVID-19 response
• Medical devices for use against coronavirus (COVID-19): List of products authorized under Interim Order No. 2
• List of designated medical devices for exceptional importation and sale