Medical Devices are classified based on their risk, ranging from Class I (lowest risk) to Class IV (highest risk), and are subject to compliance with Health Canada's Medical Devices Regulations. Class II-IV medical devices require Health Canada's approval before being sold on the Canadian market.
Medical devices in Canada are subject to compliance with Health Canada’s Medical Devices Regulations governed under the Food and Drugs Act.
Class II, III, or IV medical devices are not to be imported or sold in Canada unless the device manufacturer holds a valid medical device licence issued by Health Canada.
The term ‘medical device’ encompasses a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.
APPLICATION PREPARATION AND SUBMISSION
What can our consulting services do for you?
- Conduct a regulatory assessment to determine the risk classification of the medical device and determine the appropriate regulatory strategy for product registration
- Prepare and submit the Medical Device Licence Applications to Health Canada
- Prepare and submit Investigational Testing Authorization (ITA) Applications to Health Canada
- Review labeling and marketing materials
- Act as your regulatory authority liaison during review of your submission
- Prepare and submit post-licensing change amendments and notifications to Health Canada
The following products are examples of medical devices which require approval from Health Canada prior to market entry:
- Surgical instruments
- Surgical gloves
- Heart valves
- Hearing aids
- Bone grafts
- Hip implants
- Diagnostic test kits