Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings, and the circumstances under which such masks or face coverings would be subject to the regulatory requirements for medical devices during the COVID-19 pandemic.
Generally, non-medical masks or face coverings are made of fabric and come in various shapes, sizes and styles. They are typically sewn 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. Such masks and face coverings may help reduce the spread of respiratory droplets from the user to others or to the surroundings.
In the context of the COVID-19 pandemic:
- Masks or face coverings that make medical claims or representations to reduce the risk of or prevent the user from contracting COVID-19 are deemed medical masks. They are regulated as Class I medical devices and require medical device licensing.
- Masks or face coverings that DO NOT make any medical claims, representations or indicate they will reduce or prevent the user from contracting a disease, do not require any type of licensing.
Examples of medical claims or representations include:
- 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
Whereas examples of non-medical claims are:
- 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 coverings have 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.
All medical masks and face coverings (that make medical claims, as noted above) 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. Furthermore, the labelling for medical masks must contain clear statements on their intended use 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.
Medical masks may be authorized for sale or import into Canada through the following routes:
- 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
The regulatory pathways outlined above provide Canadians with information about the degree of protection they may expect from a medical vs. 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.
Companies importing masks/face coverings, medical or non-medical, may be requested by the Canada Border Services Agency (CBSA) to provide proof of a Medical Device Establishment Licence (MDEL). To ensure there are no hold ups at the border and that product is imported smoothly and in a timely fashion, our specialists recommend securing a MDEL for your business to be on the safe side.
As demand for medical devices, disinfectants and hand sanitizers continues to increase to keep the public safe, our team continues to work tirelessly to deliver the compliance and import solutions that are needed. Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance needs during and after licensing!