Medical device research with humans is evaluated by way of an Investigational Testing Authorization (ITA) through the Device Evaluation Division of the Medical Devices Bureau of Health Canada.
Health Canada describes a medical device as “any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state”. From this definition, medical devices can cover a wide range of uses. To further differentiate the types of medical devices out there, Health Canada has divided them into 4 different classes (Class I, II, III, and IV), Class I representing the lowest risk and Class IV representing the highest risk applications.
Manufacturers of medical devices must:
- Ensure the medical devices meet safety and efficacy requirements as laid out in the Medical Devices Regulations; and,
- Keep objective evidence to establish that a medical device meets those requirements.