With the pandemic hitting us hard, several companies are considering importing and even manufacturing respiratory masks.
The most popular mask is without a doubt the N95 or respirator with filter masks. This mask is manufactured by companies that hold a Medical Device Establishment Licence (MDEL).
Before importing masks, it is important to know that they must be approved by Health Canada. The masks must pass minimum requirements, such as filter efficiency and breathing resistance. All N95 masks certified by the U.S. National Institute for Occupational Safety and Health (NIOSH) must have an approval number stamped on the mask. Health Canada accepts the NIOSH certification.
Companies may wish to import masks that haven't been approved. Non-compliance means the product:
- is past its expiry date
- is a non-medical grade
- may not have a bilingual label
To import non-compliant masks, importers should:
- complete the HC Personal Protective Equipment (PPE) - Notification form
- include "COVID - Notification" in the subject line of the email to help Health Canada fast-track requests
- email the completed form along with a copy of the product label to hc.mdel.questions.leim.sc@canada.ca
Health Canada is fast-tracking the MDEL application process for companies that want to manufacture, import or distribute Class I masks (i.e.: Level 1 - venous pressure splash, per the American Society for Testing and Materials (ASTM)). Companies that need an MDEL application fast-tracked must:
- Fill out form FRM-0292;
- indicate in the subject line of the email: URGENT COVID-19 MDEL application for "-name of company"
- email the completed MDEL application form to hc.mdel.application.leim.sc@canada.ca
Health Canada's goal is to complete the process within 24 hours of receiving a completed request.
For further information, please do not hesitate to contact a W2C agent.Source: www.canada.ca
