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:
- surgical masks
- surgical masks with visor attachment
- face shields
- eye protection
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
- Who can sell personal protective equipment
- Supplying personal protective equipment
- Use of 3D printing manufacturing
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:
- A medical device licence authorizes a manufacturer to import or sell their Class II, III or IV medical devices.
- An interim order authorization allows a manufacturer to import or sell a medical device (Classes I to IV) for COVID-19.
- A Medical Device Establishment Licence (MDEL) authorizes:
- a manufacturer to import and sell Class I medical devices
- importers and distributors to import or sell Class I to IV medical devices.
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:
- database of Class II, III and IV medical devices licensed by Health Canada
- database of companies that have a medical device establishment licence (MDEL)
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.
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:
- are safe, effective and high quality
- meet certain regulatory standards
Detailed information can be found in the 3D printing and other manufacturing of personal protective equipment in response to COVID-19 notice, including:
- standards recommended by Health Canada for the production of face shields and face masks
- available test laboratories for product testing
- relevant regulatory authorization pathways
- Notice for industry: Ensuring predictability for interim orders relating to COVID-19
- Technical requirements for UV decontamination devices: Notice to manufacturers
- Essential services personal protective equipment (PPE) contingency reserve
- Importing and exporting medical devices
- COVID-19 mask use: Advice for community settings
- Applications for medical devices under the interim order for use in relation to COVID-19: Guidance document
- Interim order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19
- Notice: Expedited review of health product submissions and applications to address COVID-19
- Notice for industry: Mandatory reporting requirement during the COVID-19 pandemic
- Hard-surface disinfectants and hand sanitizers: Information for manufacturers
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