Class I Medical Devices
Masks (surgical, procedure or medical masks) – Level 1, 2, 3 (ATSM)
N95 respirators for medical use
Gowns – Level 2, 3 and 4
Class I medical devices do not require a medical device licence and are monitored by the Health Products and Food Branch Inspectorate (Compliance and Enforcement) through Establishment Licensing.
Products such as masks/respirators to protect against pathogens or prevent exposure to disease, surgical masks or N95 respirators intended to reduce exposure to pathogens or any product intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals is considered a medical device regulated by Health Canada.
If it is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids – it is therefore regulated as a medical device by Health Canada.
Surgical Masks and N95 Masks are Class 1 medical devices and importers are required to hold a Medical Device Establishment License (MDEL). A MDEL is issued for the activities of importing and selling medical devices for human therapeutic use in Canada.