The Government of Canada issued a notice to industry on the Regulatory considerations for importing or selling face shields.
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.
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 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.
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
More information on face shield requirements and standards, guidance documents on PPE and further information is available on the webpage here.?
If you have any questions or comments about this notice, contact the Medical Devices Directorate at email@example.com