Regulatory considerations for importing or selling face shields: Notice to industry

On this page

• About face shields
• Standards and requirements for face shields
• Regulatory authorization
• Feedback

About face shields

Personal protective equipment (PPE) can help prevent potential exposure to infectious disease. They are considered medical devices in Canada and therefore must follow the requirements outlined in  the Medical Devices Regulations.

Medical devices are classified into 4 groups (Class I, II, III and IV) based on their risk to health and safety. Class I devices, such as gauze bandages, pose the lowest potential risk, while Class IV devices, such as pacemakers, pose the greatest potential risk.

In Canada, face shields are Class I medical devices.

A face shield has a transparent window or visor that shields the face and associated mucous membranes (eyes, nose and mouth). It protects the wearer against exposure from splashes and sprays of body fluids.

Face shields are made of shatterproof plastic, fit over the face and are held in place by head straps or caps. They may be made of polycarbonate, propionate, acetate, polyvinyl chloride, or polyethylene terephthalate.

They are usually worn with other PPE, such as a medical mask, respirator or eyewear.

Health Canada strongly advises against the use of plastic bags as an alternative to face shields.

Standards and requirements for face shields

Organizations that are manufacturing face shields are advised to consult some or all of the following standards throughout the design and testing stages:

• ANSI/ISEA Z.87.1 (2015), American National Standard for Occupational and Educational Personal Eye and Face Protection Devices
• CSA Z94.3 (2020), Eye and Face Protectors
• CSA Z94.3.1 (2016), Guideline for Selection, Use, and Care of Eye and Face Protectors
• BS EN 166 (2002), Personal Eye Protection. Specifications.

Minimum specifications must be incorporated into the design and verification stages to ensure safe and effective face shields:

• Provide adequate coverage (CSA Z94.3 Sections 0.2.1/10.2.2/10.3/10.4): The size of the face shield is important because it must protect the face and front part of the head. This includes the eyes, forehead, cheeks, nose, mouth, and chin. Protection may also need to extend to the front of the neck in situations with flying particles and sprays of hazardous liquids.
• Fit snugly to afford a good seal to the forehead area and to prevent slippage of the device ^Footnote 1.
• Be made of optically clear, distortion-free, lightweight materials (CSA Z94.3.1-16 and ^Footnote 1).
• Be free of visible defects or flaws that would impede vision (ANSI Z87.1 Section 9.4).
• Be comfortable and easy to assemble, use and remove by health care professionals.
• Provide adequate space between the wearer’s face and the inner surface of the visor to allow for the use of ancillary equipment (for example, medical mask, respirator, eyewear) ^Footnote 1: The characteristics and performance requirements of face shields must not be altered when attaching shields to other protective equipment, such as hats or caps.
• Display anti-fog characteristics on inside and outside of shield (CSA Z94.3.1-16): For face shields that are not fog resistant, anti-fog spray must be provided.
• Provide user-contacting materials that have adequate material biocompatibility (skin sensitivity and cytotoxic testing) (ISO 10993-5, 10).

Other items to take note of include:

• Face shields used for protection in hospital settings do not have to be impact- or flame- resistant.
• If the device is specifically designed to withstand impact from sharp or fast projectiles, it must comply with set-out standards (ANSI Z87.1, sections 9.2 and 9.3, CSA Z94.3, section 10.1).
• For reuse, manufacturers must provide validated cleaning instructions. Sterilization procedures must not compromise the shield in any way, such as deformation or cracking.

Regulatory authorization

Most PPE, including face shields, are Class I medical devices if they are manufactured, sold or represented for use for reducing the risk of or preventing the user from infection. This includes COVID-19.

Face shields may be authorized for sale or import into Canada through the following regulatory pathways:

• Pathway 1: Interim order No. 3 authorization to import and sell medical devices related to COVID-19.
• Pathway 2: Expedited review and issuance of Medical Device Establishment Licences (MDEL) related to COVID-19. MDEL holders that import and sell face shields should take measures to ensure they are safe and effective.
• Pathway 3: Exceptional importation and sale of certain non-compliant medical devices related to COVID-19.

Note that a sale generally requires the transfer of ownership of a device from one party to another and does not necessitate any transfer of money. Applicants should carefully review the pathways and select the most appropriate authorization route for their product. For more information, see Personal protective equipment (COVID-19): How to get authorization.

If you intend to manufacture 3D print face shields in response to the COVID-19 crisis, see: 3D printing and other manufacturing of personal protective equipment in response to COVID-19

Feedback

If you have any questions or comments about this notice, contact the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca

R. J. Roberge, "Face shields for infection control: A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016.

Related links

• Interim order 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
• Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19
• Personal protective equipment (COVID-19)
• 3D printing and other manufacturing of personal protective equipment in response to COVID-19