Health Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shields are considered personal protective equipment (PPE) that helps in preventing exposure to particulates that spreads infectious diseases. A face shield has a transparent window or visor that shields the face and associated mucous membranes (eyes, nose, and mouth). They are usually worn with other PPE, such as a mask, respirator, or eyewear. Face Shields are considered as Class I medical devices in Canada and must follow the Health Canada Medical Device Regulations.1
As per the new notification, Health Canada advises face shield manufacturers to comply with the following standards in manufacturing and testing of face shields:1
- 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.
For reuse, manufacturers must provide validated cleaning instructions. In no way should sterilization procedures compromise the physical properties of the face shield.1
If you are a face shield manufacturer, face shields may be marketed in Canada through one of the following pathways:1
- Interim order authorization to import and sell medical devices related to COVID-19.
- Expedited review and issuance of Medical Device Establishment Licenses. (MDEL) related to COVID-19. MDEL holders that import and sell face shields should take measures to ensure they are safe and effective.
- Exceptional importation and sale of certain non-compliant medical devices related to COVID-19.
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1Health Canada (Aug 2020) Regulatory considerations for importing or selling face shields: Notice to industry retrieved on 09/20/2020 from https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/personal-protective-equipment/face-shields.html