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Earlier capture
Medical masks and respirators: Information for manufacturers - Canada.ca
Apr 19, 2025
legacy-hc-2025-04-21
ID 196571
Later capture
Medical masks and respirators: Information for manufacturers - Canada.ca
Jan 2, 2026
hc-20260101
ID 428989
updated9 sections changed; 1 added
9 sections changed1 added0 removed+38 / -15 linesChange ratio: 15%
--- +++ @@ -2,7 +2,7 @@ Overview Information for manufacturers Information for users-Health Canada’s role+Health Canada's role Report a problem or concern Contact us On this page@@ -27,8 +27,11 @@ sections 21 to 23 ) and-incident reporting requirements (sections 59 to 61.1)-Non-medical masks and barrier face coverings are not regulated as medical devices by Health Canada.+incident reporting requirements (+sections 59 to 61.1+)+This information must be available for review and submitted when requested. Failure to comply with the applicable regulations may result in Health Canada engaging in compliance and enforcement actions.+Non-medical masks and barrier face coverings are not regulated as medical devices by Health Canada. However, if the product label includes medical claims or representations, for example, anti-microbial claims, these face coverings become Class I medical devices. Learn more about MDELs: Guidance on medical device establishment licensing licensing exemptions@@ -43,9 +46,8 @@ (ASTM F2100) Medical face masks – Requirements and test methods (EN 14683)-We may ask manufacturers to provide evidence when they claim that they are conforming to a standard or complying with the regulatory requirements.+A medical device may claim conformity with a standard and indicate compliance with that standard on its label. In some cases we may ask manufacturers to provide evidence to support their claim of conformity to a standard. The type of evidence required depends on the standard indicated, as the standard defines the performance characteristics required for conformance. Labelling-We consider it to be a claim when a mask is labelled that it conforms to a medical device standard. The evidence that we require depends on the standard to which the manufacturer claims performance. The standard defines the performance characteristics required for conformance. Medical mask packaging should be labelled with the standard to which it claims conformance. Reusable medical masks Some medical masks may claim to be reusable up to a certain number of washes. Manufacturers of reusable medical masks should be able to:@@ -56,8 +58,15 @@ when new and unused and up to the maximum number of uses Transparent medical masks-For information on the requirements for transparent medical masks, consult:-Guidance for transparent medical mask technical specifications+Transparent medical masks should meet 1 of the following standards:+ASTM F2100+EN 14683+a comparable standard for medical mask materials+They also have some specific requirements because of their unique design that includes a transparent area (made of plastic), which may be surrounded by 1 of the following:+a filter area+a flexible element (for example, a foam strip)+For example, to demonstrate breathability, transparent medical masks should meet airflow resistance testing similar to a filtering respirator, as captured in applicable standards like CAN/CSA Z94.4.1.+For bacterial filtration efficiency, it may not be possible to test the transparent window area using test methods described in the EN 14683 or ASTM F2101 standards. In this case, an alternative internationally recognized standard designed to demonstrate resistance to penetration of microorganisms (for example, ISO 22610 or ASTM F1671) may be used. Regulating respirators Manufacturers of respirators are expected to meet certain requirements before they import or sell in Canada. Regulatory considerations@@ -79,7 +88,7 @@ breathing resistance particulate filtration efficiency Respirators can be tested to Canadian standards or other international standards, such as:-Canada: Performance of filtering respirators (CAN/CSA Z94.41)+Canada: Performance of filtering respirators (CAN/CSA Z94.4.1) US: Code of Federal Regulations Part 84 (NIOSH 42) European Union: Performance of filtering respirators (EN 149) China: Respiratory protection - Non-powdered air-purifying particle respirator (GB2626)@@ -102,10 +111,13 @@ of fluid penetration and flammability testing. Fluid penetration testing should be conducted in accordance with ASTM F1862/F1862M, as well as the respirator labelled with the barrier level achieved in this test. Flammability testing should be conducted in accordance with 16 CFR 1610. It may be acceptable to test these characteristics using other standards. The manufacturer should provide a rationale if they use another standard.+Key indicators we consider when determining whether safety and effectiveness requirements have been met include:+compliance with standards+performance requirements Labelling The label of a respirator should indicate the standard to which it conforms. For example, CSA-approved respirators and filters for reusable respirators must be labelled with the following: manufacturer name, logo or identifying mark-a way to trace it chosen by the manufacturer (for example, a lot number)+a way to trace it that is chosen by the manufacturer (for example, a lot number) reference to CSA Z94.4.1:21 part number or identifying mark filter classification (for example, CA-N95 or CA-PAPR100-N)@@ -117,7 +129,7 @@ and device name and model number Biocompatibility-Health Canada may ask manufacturers to provide evidence that their medical mask or respirator complies with the regulatory requirements to demonstrate the biocompatibility of the device. This usually involves providing evidence that the device is+Medical masks and respirators must meet safety and effectiveness requirements under the regulations including biocompatibility. A mask or respirator is biocompatible when it is not : cytotoxic (tested in accordance with ISO 10993-5)@@ -128,7 +140,7 @@ in vivo animal tests requires scientific justification sensitizing (tested in accordance with ISO 10993-10)-Depending on the materials used in the device, it may be acceptable to demonstrate biocompatibility by comparing materials with an identical or very similar device that's available in Canada.+Health Canada may ask manufacturers to demonstrate the biocompatibility of their devices, such as by submitting biocompatibility evidence. Depending on the materials used in the device, it may be acceptable to demonstrate biocompatibility by comparing materials with an identical or very similar device that's available in Canada. Nanomaterials or other coatings Some medical masks and respirators may contain nanomaterials or coatings made from other substances. These coatings are usually intended to destroy or inhibit the growth of bacteria and viruses contacting the mask surface. Examples of the materials used in these coatings include:@@ -151,10 +163,21 @@ For example, if: the evidence indicates a coating destroys 99% of viral particles after 1 hour of contact with the mask surface, the label should clearly indicate this the label only says the device destroys 99% of viral particles without indicating the time it takes, users may wrongly assume that viruses are destroyed immediately upon contact with the mask-For more information on regulatory considerations for nanomaterials or other coatings used with medical masks or respirators, consult:-Notice on technical requirements for anti-microbial claims for medical masks+Safety and effectiveness requirements for antimicrobial claims+Medical masks and respirators, including those with antimicrobial claims, must meet safety and effectiveness requirements under the regulations.+If we have reasonable grounds to believe that a mask or respirator may not meet these requirements, we may request that the manufacturer submit an analysis or other information to help us make that determination. For example, we may request:+a list of the materials with antimicrobial or antiviral properties and their technical specifications (for example, physical/chemical properties)+a full description of how the antimicrobial or antiviral technology (for example, coatings) is produced and incorporated into the mask, as well as a description of the expected antimicrobial or antiviral action+if the antimicrobial substances are present in nanoform(s), a characterization of those substances (for example, thickness, charged sites), including a certificate of analysis showing impurities+information describing potential inhalation exposure to the materials with antimicrobial or antiviral properties that includes:+summarized test data that characterize the amount and size of particulates that are shed during typical use+the inhalation exposure range estimates in terms of mg/L/hr and mg/kg-bw/day+evidence to support all antiviral or antimicrobial claims, or both, made on the product label+anti-microbial effectiveness claims should be stated in terms of the magnitude of decrease in the number of organisms (that is, log reduction) and the conditions under which the claimed reduction can be expected to occur (that is, time, temperature)+If a claim is made that the mask can be washed and re-used, evidence+must be provided+that the antimicrobial claims are maintained after a proposed maximum number of wash cycles as indicated in the device labelling. Related links Medical Device Regulations Page details-Date modified:-2024-06-12+2025-06-26