Regulatory considerations on the classification of respirators
Date published: 2020-10-20
This notice explains the circumstances under which certain respirators would be subject to the regulatory framework for medical devices during the COVID-19 pandemic.
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A respirator, also known as particulate filtering facepiece respirator (FFR), is a piece of personal protective equipment (PPE) that forms a tight seal against the skin of the wearer. It's used to reduce the risk of inhaling hazardous airborne particles and aerosols, including dust particles and infectious agents. All FFRs are labelled to provide respiratory protection to the wearer. Unlike respirators, medical masks are looser in fit and do not provide the same level of filtration.
As outlined in this notice, Health Canada has categorized single-use respirators into 3 types for the purpose of regulatory oversight:
In the context of COVID-19, commercial respirators are used in settings such as:
- retail locations
- living spaces when self-isolation is required
- workplaces where there is not enough room for physical distancing such as:
- light industries
- health care facilities
Commercial respirators are intended to reduce the risk of the user and of others contracting COVID-19 and other infectious agents when physical distancing is not possible.
Surgical respirators are commercial respirators that have been designed and tested for fluid resistance and flammability. Health care professionals and health care facilities use them for medical, surgical and other high-risk procedures. In some jurisdictions, medical respirators may be equivalent to surgical respirators.
Industrial respirators are intended for use in construction, welding and renovations to protect the wearer from inhaling dust, welding fumes, fiberglass, etc. in an industrial setting.
Elastomeric respirators are excluded from this notice.
In Canada, before 2020, the most common respirators were those that had been evaluated, tested and certified by the US National Institute for Occupational Safety and Health (NIOSH). These NIOSH-approved FFRs are labelled N95, N99, N100, P95, P99, P100, R95, R99 and R100. The N, R and P designations refer to the filter's oil resistance:
- N, not resistant to oil
- R, somewhat resistant to oil
- P, strongly resistant to oil
NIOSH-approved respirators also have an approval number stamped on the respirator as TC-84A-####n.
Canadian consumers are now accessing:
- FFRs imported from China, Korea and Europe
- new products manufactured in Canada (95PFE)
Other, equivalent FFRs with at least 94% filtration are labelled in accordance with international standards (for example, KN95, KP95, KP100, KF94 or FFP2).
Before COVID-19, protection against infectious particles wasn't required in most public or commercial spaces. Infectious particles include:
- viruses such as influenza viruses
- bacteria such as M. tuberculosis
Commercial respirators are represented as providing submicron (0.03 µ) particle filtration rates in excess of 94%. The WHO's interim guidance and a toolkit by the US Occupational Safety and Health Administration (OSHA) suggest they can be used as a component of PPE during the COVID-19 pandemic to provide both source control and protection to the wearer.
Surgical FFRs need to meet the minimum requirements of filtration performance in order to protect the user. They're designed to pass occupational fit testing requirements in order to maximize the particulate filtration efficiency. Some surgical respirators also meet ASTM F2100 standards for bacterial filtration efficiency. They're also tested for fluid resistance and flammability.
Industrial respirators available to the general public and not governed by Ministry of Labour regulations are designed for use in industrial settings. Such respirators may also be able to filter small particles with viruses and bacteria. However, these respirators should not make claims that they target specific pathogens because they're not tested for this purpose. Furthermore, these FFRs often have exhalation valves, which means they can release infectious respiratory droplets outside the respirator.
Commercial respirators are regulated under the Food and Drugs Act as Class I medical devices in Canada if they're manufactured, sold or represented to reduce the risk of, or prevent the user from, contracting a disease such as COVID-19. All surgical respirators are Class I medical devices.
Commercial respirators would be considered Class I medical devices if they either:
- include any drugs, biologics or anti-microbial/anti-viral agents
- claim FDA, CE or other regulatory approval as a medical device
- make anti-viral (virucidal) or anti-bacterial (bactericidal) claims
- don't have exhalation valves in the absence of industrial use indication
- are labelled or promoted for use to protect the wearer from COVID-19 or other infectious particles
- are labelled, promoted or represented as meeting a recognized filtration efficiency rating (for example, N95, 95PFE, KN95) without a clearly stated industrial purpose or
- are labelled with an appropriate international standard without a clearly stated industrial purpose
Note: A commercial respirator labelled with the statement "not for medical use" may still be classified as a medical device if it has any of the listed characteristics, medical claims or representations.
All surgical respirators are Class I medical devices. In addition to the labelling considerations for commercial respirators, they should be labelled:
- as fluid resistant with the level of resistance provided
- with the flammability standard, if met
Industrial respirators should be explicitly labelled as not for infection prevention or control in order not to be considered a medical device.
Labelling for industrial respirators should include language to indicate its industrial purpose such as:
- "not for infection prevention or control"
- "for industrial use only"
Industrial respirators with none of the claims or indications listed for commercial or surgical respirators:
- are not considered medical devices
- would not be regulated under the Food and Drugs Act
Industrial respirators may be labelled with a filtration efficiency and NIOSH-certified (for example, N95) so long as their intended industrial purpose is clear. These types of respirators are regulated under the Canada Consumer Product Safety Act.
Regulatory Class I pathways
Respirators may be authorized for sale or import into Canada through 1 of 3 regulatory pathways:
- interim order authorization to import and sell medical devices related to COVID-19
- expedited review and issuance of a Medical Device Establishment Licence (MDEL) 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.
If you have any questions or comments about this notice, contact the Medical Devices Directorate at firstname.lastname@example.org.
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