Personal protective equipment (COVID-19): Overview

On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. Health Canada will be updating the content of this page soon. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.

Personal protective equipment (PPE) are items worn to provide a barrier to help prevent potential exposure to infectious disease. These items include:

Personal protective equipment sold for medical purposes are classified as medical devices in Canada. Under the Medical Devices Regulations, medical masks, N95 respirators, medical gowns, face shields and medical goggles are Class I medical devices. Medical gloves are Class II medical devices.

On this page

Expedited access

There is an unprecedented demand and urgent need for products to help limit the spread of COVID-19. As a temporary measure, Health Canada is speeding up the authorization processes for personal protective equipment.

Who can sell personal protective equipment

With some exceptions, authorization by Health Canada is required before medical devices can be imported and sold in Canada.

There are different medical device authorizations depending on the role of the company (manufacturer, importer or distributor) and the class of medical device:

To obtain Health Canada authorization to import or sell PPE, see the section on how to get authorization.

Authorized medical devices and licence holders are listed in one of the following lists or databases:

As well as these medical device databases, additional authorization lists related to COVID-19 medical devices have been created. This is a result of new mechanisms put in place for expedited access to COVID-19 medical devices:

Health Canada is also allowing certain medical devices that may not fully meet Canadian regulatory requirements but are manufactured to comparable standards to be imported and sold. This is being done through an exceptional import and sale interim order:

Supplying personal protective equipment

Canada needs products and services to meet the unprecedented demand due to the COVID-19 pandemic. These include personal protective equipment such as medical masks, N95 respirators, gloves and gowns.

The full list of products and services needed is on Buyandsell.gc.ca. You can also find information on product specifications.

Suppliers authorized to sell in Canada and able to provide products or services that are needed in support of Canada’s response to COVID-19 are asked to complete a submission form.

Use of 3D printing manufacturing

Health Canada recognizes that organizations may be looking at innovative manufacturing approaches, such as 3D printing, to produce PPE for health care workers. These organizations may include non-traditional manufacturers, such as research and academic institutions, and other industry sectors.

While we support efforts to increase the availability of personal protective equipment to support the COVID-19 pandemic, there are technical requirements to consider. These requirements were established to ensure that medical devices:

Detailed information can be found in the 3D printing and other manufacturing of personal protective equipment in response to COVID-19 notice, including:

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