On July 24, 2020, Health Canada published a notice to industry that explains circumstances under which non-medical masks or face coverings would be subject to the regulatory framework for medical devices during the COVID-19 pandemic.
Non-medical masks or face coverings which are generally made of fabric may help reduce the spread of respiratory droplets from the user to others or to the surroundings. Since May 20, 2020, Canadians have been advised to wear face covering in public settings considered to pose increased risk of COVID-19 transmission.
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 and 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.
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 and 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 etc.
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.
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.
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. Health Canada is actively monitoring the development of standards for face coverings and may revise our position when new information becomes available.
Reference:
Regulatory considerations on the classification of non-medical masks or face coverings: Notice to industry (Dated July 24, 2020) - https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/personal-protective-equipment/medical-masks-respirators/face-covering-classifications-notice.html
Author: Preetha Prabhu