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Face shields have gained utmost significance as the primary protective equipment to curb the spread of the COVID-19. Considered as a Personal Protective Equipment (PPE), face shield is made up of a transparent window or visor, that protects the face and associated mucous membranes (eyes, nose and mouth) against the potential exposure to infectious diseases. To guide manufacturers in these rapidly increasing market demands, Health Canada has devised several Regulatory standards and authorization pathways for importing or selling face shields.
In Canada, the PPE is considered as a medical device and is obliged to follow the standard requirements outlined in the Medical Devices Regulations. Based on their risk to health and safety, the medical devices are classified into 4 groups (Class I, II, III and IV) and the face shields are considered as Class I medical devices. For compliance, Health Canada recommends the face shield manufacturers to align with some or all of the following standards throughout the design and testing stages:
Health Canada Standards for Face Shields
- 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 and Specifications
To ensure the production of safe and effective face shields, minimum specifications must be incorporated during the design and verification stages. They include:
- Device should fit snugly to afford a good seal to the forehead area and to prevent slippage of the device
- Device should be made of optically clear, distortion-free, lightweight materials
- Device should be free of visible defects or flaws that would impede vision
- The device should provide adequate space between the user’s face and the inner surface of the visor to allow the use of ancillary equipment
- Device should display anti-fog characteristics on inside and outside of shield, if available
- The device should provide user-contacting materials with adequate material biocompatibility
- The device need not be impact- or flame- resistant, if used for protection in hospital settings
- The device should withstand impact from sharp or fast projectiles
- The device must provide validated cleaning instructions for re-use
Regulatory Authorization
To authorize, sale or import face shields into the Canadian market, manufacturers should keenly review the following Regulatory pathways and select the appropriate authorization route for their product:
- Pathway 1: Interim order 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
- Pathway 3: Exceptional importation and sale of certain non-compliant medical devices related to COVID-19
While Health Canada has devised the aforementioned regulations and registration pathways for face shields, manufacturers aiming for the Canadian market-entry are obliged to adhere to the required procedural activities. To forgo last-minute challenges, get in touch with regional Regulatory expert for streamlined market-entry. Stay informed. Stay compliant.
