Health Canada published a notice on 21 April 2021 that outlines the safety and effectiveness requirements for Class I medical masks and face coverings with anti-microbial claims. This notice is for manufacturers using either an interim order (IO) authorization or medical device establishment licence (MDEL) to manufacture, import or sell these devices in Canada.
This notice does not cover anti-microbial agents sold separately and applied to face coverings or medical masks prior to use.
Face coverings are not classified as medical devices unless there are medical claims or representations.
Some mask and face covering medical devices may incorporate or be coated with materials that claim to be anti-microbial. Anti-microbial substances may kill or inhibit the growth of microorganisms. Some examples of anti-microbial substances include, but are not limited to:
- silver
- copper
- Nanoform Graphene fabric coatings
- salt
In Canada, face coverings that are used only to reduce droplets or aerosols passing between individuals are not regulated as medical devices. However, if the product label includes anti-microbial claims, these face coverings become Class I medical devices.
Section 25 of the Medical Device Regulations allows for the request of supporting safety, effectiveness and quality information from Class I manufacturers.
Limitations to the claims
Bacterial Filtration Efficiency (BFE) is a measurement of a medical mask material’s resistance to penetration of a specific kind of microbe: a 3 µm (300 nm) in diameter bacteria. Results are reported as percent efficiency and correlate with the ability of the fabric to resist bacterial penetration. Higher BFE percentages in this test indicate better barrier efficiency. In general, a BFE rating could be interpreted as material filtration efficiency.
This measurement is not to be taken in isolation and without a reference to a test method or international standard. To achieve a high level of filtration, anti-microbial non-medical masks should be manufactured from a non-woven polypropylene material. All claims must be supported by evidence and available for review upon request.
Medical masks or other personal protective equipment claiming microbial protection should meet the safety and effectiveness requirements described below. This information must be available for review upon request in the case of MDEL holders. It should be submitted by manufacturers filing an interim order (IO) application or responding to regulatory requests for information.
Review the notice for complete details and more information relating to the medical masks.
Other information
- Interim order no. 2 respecting the importation and sale of medical devices for use in relation to COVID-19 guidance document
- Applications for medical devices under the interim order for use in relation to COVID-19 – Guidance document
- Medical Device Establishment Licence (MDEL) application
- Notice: Expedited review of health product submissions and applications to address COVID-19