Medical masks and respirators: Health Canada’s role
On this page
What we do
Health Canada regulates all medical devices for sale in Canada. All makes and models of medical masks and respirators sold in Canada must be sold by someone with a medical device establishment licence (MDEL) issued by Health Canada.
To help ensure that medical masks and respirators are safe and effective, we can, when necessary:
- conduct post-market surveillance activities and
- use compliance and enforcement actions
Post-market surveillance
After the manufacturer or the distributor of a mask or respirator receives an MDEL, we monitor the device for its safety, effectiveness and quality.
As part of our post-market surveillance activities, we may:
- monitor problem and incident reports that come from consumers, manufacturers, health care providers and other sources
- follow up on reports about medical device problems
- reports are put in order of priority based on the risk to health and safety
- ask for additional information from manufacturers or individuals who report incidents
- recall a medical device
We consider compliance with the standards and performance requirements when determining whether safety and effectiveness requirements have been met.
Learn more:
- Sections 10 to 20 of the Medical Devices Regulations (regulations)
- Recognized standards for medical devices
For information on how to report a problem or concern with a mask or a respirator, please refer to the Report a problem or concern section.
If you have questions or concerns about the risks and safety of medical masks or respirators, please send an email to mdd.postmarket-postcommercialisation.dim@hc-sc.gc.ca.
Compliance and enforcement
We use compliance and enforcement actions to help mitigate risk for devices on the market.
To do this, we may:
- conduct MDEL inspections to ensure a company is complying with the regulations
- seize a medical device
- stop the sale of a medical device
- recommend that imported devices be refused or seized at the border
- suspend an MDEL
- issue public advisories or other forms of risk communications
- request a voluntary recall or issue a mandatory recall
Compliance and enforcement policy for health products (POL-0001)