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

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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:

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

Other items to take note of include:

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:

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 hc.meddevices-instrumentsmed.sc@canada.ca

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

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