Regulatory considerations on the classification of non-medical masks: Notice to industry

Find information on the requirements for getting medical devices authorized in Canada on the medical devices page.

Date published: July 24, 2020
Updated: April 21, 2021

This notice explains under which circumstances non-medical masks or face coverings would be subject to the regulatory framework for medical devices during the COVID-19 pandemic.

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About non-medical masks

Similar to medical masks, non-medical masks may help reduce the spread of respiratory droplets from the user to others or to the surroundings. They do not have a tight seal around the nose and mouth, unlike respirators, limiting their ability to provide respiratory protection. For this reason, respirators are primarily designed and fitted to the user's face. This allows for a much higher degree of respiratory protection of potentially infectious particles compared to loose-fitting masks. Even when the product claims to provide filtration protection, loose-fitting masks offer limited protection due to the air spaces between the fabric and the user's face.

Non-medical masks are generally made of a variety of different fabrics, such as cotton, and come in a range of shapes and styles. Most often, they are sewn masks and secured with ties or straps around the head or behind the ears. They may be made in a factory, by a home-based small business or hand-made by people for self-use or donation to others.

Since May 20, 2020, Canadians have been advised to wear masks when in the community. The Federal-Provincial-Territorial (FPT) Special Advisory Committee on COVID and the Public Health Agency of Canada (PHAC) recommended that people wear masks when:

Many public health authorities are now requiring the wearing of non-medical masks in public settings considered to pose increased risk of COVID-19 transmission. At this time, it is understood that non-medical masks do not provide a complete barrier to virus-sized particles produced by the wearer when speaking, laughing, singing, coughing or sneezing. While it has not been proven that they protect the wearer from exposure to the infectious respiratory droplets of others, it is reasonable to believe that some protection may be provided. The level of protection depends on the materials and methods used, and most importantly, how it fits.

Wearing non-medical masks are an additional personal practice, along with proper hand washing and physical distancing. Covering one's mouth and nose help reduce the spread of respiratory droplets.

For more information on non-medical masks and their limitations, please refer to COVID-19 mask use: Advice for community settings.

Regulatory considerations

In the context of the COVID-19 pandemic, face coverings with medical claims or representations are considered medical devices and are regulated as such.

This approach allows for greater regulatory oversight of face coverings used for medical purposes. It also eases the way for Canadians to access non-medical face coverings that can help reduce the spread of respiratory droplets. Furthermore, this approach will provide Canadians with information about the degree of protection they may expect from a non-medical mask or face covering. This will allow them to select a product based on their individual risk profile. For example, people who are at risk of more severe disease if infected with COVID-19 may wish to use a mask with an established higher level of protection.

Masks regulated as medical devices (medical masks)

Masks that make medical claims or representations to reduce the risk of or prevent the user from contracting the virus that causes COVID-19 are regulated as Class I medical devices.

Some medical claims or representations include the following statements:

Masks with such claims must have supporting evidence to validate their claims, as well as evidence of standards in support of equivalence to a medical mask. Such products may be authorized for sale or import into Canada through the following regulatory pathways:

For details on the authorization pathways, please refer to COVID-19 medical masks and respirators.

All medical masks regulated as medical devices must meet specific international standards for Class I medical devices, such as ASTM F2100. These standards include requirements for bacterial filtration effectiveness, fluid resistance and differential pressure. They may include specifications for particle filtration efficiency, flammability and microbial cleanliness.

Labelling for medical masks must contain:

Medical masks must come with bilingual labelling, either on the packaging or with the device itself.

Non-medical masks

Non-medical masks are primarily used as a form of general source control i.e. to help protect others from the spread of SARS-CoV-2 by an infected wearer. For example, they may reduce cross-transmission in persons who don't have symptoms but may have the virus that causes COVID-19 without knowing it and may unknowingly pass the virus to someone else.

Some masks are not regulated as medical devices. These are masks that do not make medical claims or indicate they will reduce or prevent the user from contracting a disease. Non-medical claims include the following statements:

A number of reference documents outline the preferred material, design and best practices for wearing non-medical masks. These include:

These documents are different from the standards that apply to medical masks, as non-medical masks may not protect the user from external respiratory droplets. As well, the filtration capability of a face covering depends on a number of factors, such as the design, seams, material, number of layers and how it fits an individual.

Health Canada has not set out or endorsed any standards for non-medical masks at this time. We are actively monitoring the development of standards for non-medical masks and may revise our position when new information becomes available.

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