Medical masks and respirators: Information for manufacturers

On this page

• Regulatory requirements
• Regulating medical masks
• Regulating respirators
• Biocompatibility
• Nanomaterials or other coatings

Regulatory requirements

Medical masks and respirators are regulated by Health Canada as Class I medical devices under the Medical Device Regulations (regulations).

Manufacturers, importers and distributors of Class I medical masks and respirators must have a medical device establishment licence (MDEL) before they can import or sell in Canada. There are exceptions for:

• manufacturers of medical masks or respirators that import or distribute solely through a person that holds a MDEL
• retailers and health care facilities, as they do not need an MDEL

The responsibilities of an MDEL holder are described in section 45 of the regulations. MDEL holders must demonstrate to Health Canada that they have met the regulatory requirements. They must also have applicable documented procedures in place for the medical devices that they import or distribute.

A medical device licence is not required for Class I devices. However, manufacturers must comply with the following requirements set out in the regulations:

• safety and effectiveness requirements (sections 10 to 20)
• labelling requirements (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.

Learn more about MDELs:

• Guidance on medical device establishment licensing
  • licensing exemptions
• Responsibilities of MDEL holders

Regulating medical masks

Manufacturers of medical masks are expected to meet certain requirements before they import or sell in Canada.

Regulatory considerations

Masks are regulated as Class I medical devices if they are sold or represented for a medical purpose. For example, they help to prevent the spread of germs from the user to others or protect the user from germs.

Medical mask standards

Medical masks should conform with 1 or more medical mask standards, such as:

• Standard specification for performance of materials used in medical face masks (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.

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:

• demonstrate that the cleaning process can disinfect the mask, especially if it's intended for more than 1 user
• identify a maximum number of uses or cleaning cycles before the mask should be disposed
• provide a step-by-step cleaning and reprocessing process for users to follow
• demonstrate that the mask conforms to a medical mask standard, if making claims
  • 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

Regulating respirators

Manufacturers of respirators are expected to meet certain requirements before they import or sell in Canada.

Regulatory considerations

Respirators are regulated as Class I medical devices if they are sold or represented for a medical purpose. For example, they help to prevent the spread of germs from the user to others or protect the user from germs.

All surgical respirators are Class I medical devices.

Industrial respirators are not considered medical devices and are not regulated under the Food and Drugs Act if they:

• have none of the claims or indications listed for medical use
• are labelled as "not for infection prevention or control" or "for industrial use only" to indicate its industrial purpose

Like respirators with medical claims, industrial respirators may be labelled with a filtration efficiency and be NIOSH-certified (for example, N95) as long as their intended industrial purpose is clear. These types of respirators are regulated under the Canada Consumer Product Safety Act.

Respirator certification

Certification organizations like the Canadian Standards Association (CSA) Group and the US National Institute for Occupational Safety and Health (NIOSH) evaluate, test and certify respirators. Certified respirators must pass minimum performance requirements, such as:

• fit testing
• 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)
• 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)

Certified respirators will have a symbol of the certification body. Manufacturers should be able to provide evidence of certification for respirators that are labelled with a certification symbol.

For symbols, visit:

• NIOSH
• CSA Group
  • also lists CSA-certified respirators

We may request evidence from respirator manufacturers that their respirators have been certified according to 1 or more of these standards. Alternatively, manufacturers can provide test reports that demonstrate their device is equivalent to a certified device.

In addition to standard respirator performance testing or certification, manufacturers of elastomeric and reusable respirators should:

• define a regular interval or set of conditions for when the filters should be replaced
• provide a step-by-step cleaning and reprocessing process for users to follow
• provide the cleaning and reprocessing instructions for consumers included in or on the packaging
• conduct validation studies of the cleaning and reprocessing procedure to demonstrate that it adequately cleans and disinfects the reusable parts of the respirator
• identify cleaning agents to use (for example, disinfectants with a Canadian drug identification number (DIN))

We may request evidence from manufacturers of surgical respirators 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.

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)
• reference to CSA Z94.4.1:21
• part number or identifying mark
• filter classification (for example, CA-N95 or CA-PAPR100-N)
• an indication if it's only to be used once, if applicable

Each respirator standard has its own labelling requirements. Manufacturers must conform with these requirements to remain in compliance with the standard.

Respirators that have not been certified by a certifying body should at least be labelled with the following:

• particulate filtration efficiency
• manufacturer name 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 not:

• cytotoxic (tested in accordance with ISO 10993-5)
• irritating (tested in accordance with ISO 10993-10 or ISO 10993-23)
  • using the in vitro irritation tests described in ISO 10993-23 instead of 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.

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:

• nanosilver
• silver chloride
• copper
• graphene

To date, there are no safety standards that directly address the use of nanomaterials or other coatings in respirators and medical masks. Instead of specific standards, we refer to the NIOSH-recommended exposure limit (REL) and the Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL).

Learn more about these limits:

• NIOSH pocket guide to chemical hazards

Coating substances should be strongly fixed to the device to reduce the chance of particulates shedding and being accidentally inhaled.

The total mass of coating used in the mask should not be greater than the NIOSH's REL or OSHA's PEL limit, whichever is less. If the total mass is greater, manufacturers must be able to demonstrate that:

• the amount of substance shed under worst-case conditions is less than that limit
  • an example of a worst-case scenario would be rapid high-volume respiration, such as during intense exercise
• shedding does not surpass the limit after extended use
  • for example, at the end of an 8-hour period

We may ask manufacturers to provide scientific evidence to:

• demonstrate the substances used in coated masks do not pose a heath hazard to users
• support the claims made about the coating

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

Related links

• Medical Device Regulations