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

Date published: July 24, 2020

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 or face coverings

Non-medical masks or face coverings may help reduce the spread of respiratory droplets from the user to others or to the surroundings.

Non-medical masks or face coverings are generally made of fabric 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 face coverings 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 face coverings when:

Many public health authorities are now requiring the wearing of non-medical masks or face coverings in public settings considered to pose increased risk of COVID-19 transmission. At this time, it is understood that face coverings 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 face coverings 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 face coverings and their limitations, please refer to non-medical masks and face coverings.

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.

Face coverings regulated as medical devices (medical masks)

Face coverings that make medical claims or representations to reduce the risk of or prevent the user from contracting COVID-19 are medical masks. They are regulated as Class I medical devices.

Some medical claims or representations include the following statements:

Medical masks 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, including face coverings 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, and may include specifications for particle filtration efficiency, flammability and fluid resistance.

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 or face coverings

Some face coverings 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 face coverings. These include:

These documents are different from the standards that apply to medical masks, as face coverings may not protect the user from external respiratory droplets. As well, the filtration capability of a face covering depends on factors such as design, seams, material, layering and shape.

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

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