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.