Regulatory considerations on the classification of non-medical masks: Notice to industry
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.
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:
- it is not possible to consistently maintain a 2-metre distance from others, particularly in crowded public settings
- the local epidemiology and rate of community transmission warrant it
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.
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:
- to protect the user from contracting COVID-19
- for anti-viral or anti-bacterial protection (for example, contains a drug or biologic)
- for use as a medical mask
- to provide liquid barrier protection
- designed as a respiratory protective device (for example, used for particulate filtration)
- for use in high-risk aerosol generating medical procedures
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:
- interim order authorization to import and sell medical devices related to COVID-19
- expedited review and issuance of Medical Device Establishment Licences related to COVID-19
- exceptional importation and sale of certain non-compliant medical devices related to COVID-19
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:
- clear statements on their intended use (for instance, the purpose for which the device is manufactured, sold or represented) and
- the specific performance standard, including performance specifications for their proper use (for example, filtration efficiency and fluid resistance).
Medical masks must come with bilingual labelling, either on the packaging or with the device itself.
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:
- Non-medical masks can play an important role in situations where physical distancing is not possible or is unpredictable.
- When worn properly, a person wearing a non-medical mask may reduce the spread of their respiratory droplets.
- These non-medical masks have not been tested to meet any standards. Although encouraged, wearing a non-medical mask is not a substitute for physical distancing and hand washing.
A number of reference documents outline the preferred material, design and best practices for wearing non-medical masks. These include:
- AFNOR Spec - Barrier masks V1.0 by the French Standardization Association
- Community face coverings - Guide to minimum requirements, methods of testing and use (CWA 17553:2020) by the European Committee for Standardization
- BNQ Attestation document 1922-900, an attestation program for masks established by the province of Québec and certified by le Bureau de normalisation du Québec
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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