The notice to industry 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
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 wearface coverings.
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 under Health Canada.
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:
- 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
Medical masks 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, 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:
- clear statements on their intended use (for instance, the purpose for which the device is manufactured, sold or represented) and
- specific 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 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:
- Face coverings 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 or face covering may reduce the spread of their respiratory droplets.
- These non-medical masks or face coveringshave not been tested to meet any standards. Although encouraged, wearing a non-medical mask or face covering 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 face coverings. 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
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.
More information on masks: