Personal protective equipment (COVID-19): How to get authorization

On this page

Authorization from Health Canada is required prior to the import or sale of personal protective equipment for medical purposes.

There are different routes to obtaining Health Canada authorization to supply COVID-19 medical devices. The routes depend on 2 things:

  1. whether the company bringing the product to market in Canada is a manufacturer, importer or distributor
  2. the risks associated with the medical device

Medical devices are classified based on their associated risks. Under the Medical Devices Regulations, N95 respirators, medical masks, face shields or medical goggles, and medical gowns are Class I medical devices.

Medical gloves are Class II medical devices.

Regulatory authorization pathways for COVID-19 medical devices

For Class I medical devices, such as N95 respirators, masks, face shields, goggles, and gowns, applications can be made through either the:

or

To be sold in Canada, Class II-IV medical devices, such as medical gloves, require a medical device licence or an interim order authorization. 

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

Pathway 1: Interim order authorization for importing and selling medical devices

The interim order (IO) to import and sell allows Health Canada to expedite authorizations for the import or sale of medical devices related to COVID-19.

Important information about this pathway:

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

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 asking to manufacture Class I, or import or distribute Class I to IV medical devices in relation to COVID-19. 

Due to the high number of MDEL applications received, Health Canada issued temporary submission numbers (SN) in advance of the MDEL between April 22 and May 22, 2020, to facilitate quicker access to products needed to help combat COVID-19.

SNs were issued to MDEL applicants that submitted the critical information required to ensure effective oversight of the activity being licensed. Companies conducting activities using a submission number are subject to all of the same safety requirements as MDEL holders. This temporary number can also be used at the border to allow importation.  

Health Canada is contacting SN holders to either issue or refuse to issue an MDEL following the application review. Following this, the temporary submission number is no longer valid.

Important information about MDELs:

To submit an MDEL application:

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

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

Pathway 3: Exceptional importation and sale of certain medical devices to help prevent or alleviate shortages

A regulatory pathway has been created to facilitate access to PPE that may not fully meet the regulatory requirements, but are made to comparable standards. This is being done through an exceptional import and sale interim order.

This pathway includes medical devices that:

Important information about this access pathway:

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

  1. complete the medical devices interim order request form
  2. email the completed form along with a copy of the product label to hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca

After reviewing the request, we will 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 by completing the Exceptional importation and sale notification form to import a designated device at least 5 calendar days before the device is imported. 
  2. Send your notification to hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca.

Responsibilities of authorization and licence holders importing and selling personal protective equipment

Applicants are responsible for ensuring that imported and sold products comply with the Medical Devices Regulations. This includes ensuring that:

Health Canada will conduct site inspections and spot checks to verify compliance. We will take immediate action when non-compliance is confirmed. This includes stopping the importation and sale of any products that are found to pose a risk to the health to Canadians.

Related links

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: