Understanding Health Canada Medical Device Licensing

Understanding Health Canada Medical Device Licensing

When browsing through our online shop, you may have noticed the phrase “Health Canada Approved” in our product descriptions. While this may give you an additional layer of peace and security when purchasing from us, you may be wondering exactly what this licensing entails, whether it is necessary, and what a manufacturer must do to obtain one. In this article, we share more with you about Health Canada Medical Device Licensing and why it means you can buy our products with confidence.

Defining Medical Device

First, we have to understand what is meant by a medical device. In Canada, this refers to any device that is used in the diagnosis, treatment and prevention of a disease or physical condition. Some examples include:

  • Wheelchairs and hospital beds
  • Thermometers
  • Pulse oximeters
  • Valves
  • Test kits
  • Diagnostic instruments
  • Surgical instruments such as gloves
  • Pacemakers
  • … and many more!

Different Classifications of the Medical Device License (MDL)

Class I:

  • Gowns (e.g., chemotherapy gowns, surgical gowns, or isolation gowns)
  • Face shields
  • N95 respirators
  • KN95 respirators
  • Surgical masks
  • Medical masks
  • Procedure masks

Class II:

  • Pulse oximeters
  • Infrared thermometers
  • Digital thermometers
  • Examination and surgical medical gloves
  • Manual resuscitation bags
  • Endotracheal tubes
  • Portable and stationary aspirators
  • Oxygen Concentrators
  • Laryngoscopes

Class III:

  • Pulse Oximeters (for continuous monitoring)
  • Anesthesia delivery devices
  • Infusion pumps
  • Dialyzers
  • Vital sign monitors
  • Ventilators
  • Bi-level positive airway pressure machines

Health Canada currently assesses and monitors the effectiveness and safety of all products as per Interim Order No. 2. The regulatory body carries out expedited evaluations of applications regarding COVID-19 medical devices. At LOOKEE® Tech, we are a Medical Device License (MDL) and Medical Device Establishment License (MDEL) holder. We offer Health Canada approved pulse oximeters to help Canadians manage and monitor their health during the COVID-19 pandemic.

Purchase Health Canada Approved Medical Devices from LOOKEE® Tech

We understand that there is a wide range of illegal, unlicensed, and knockoff pulse oximeters being imported from overseas to Canada. That’s why it can give our Canadian customers peace of mind when our products are Health Canada MDL licensed. To this end, you can shop with confidence at LOOKEE® Tech knowing that our products have been approved after passing strict tests for health data accuracy, safety, and efficacy.

Our Breeze Infrared Thermometer and Deluxe Fingertip Pulse Oximeter have been approved by Health Canada and designed with the latest technology in mind. On top of that, all our products come with a one-year warranty so you can shop and use them with full assurance. If you have any more questions regarding our products or medical device licenses by Health Canada, please feel free to contact us for more information.