Health Canada Regulatory Consulting
Health Canada welcomes pre-submission engagement, and in many cases Health Canada approval can be obtained earlier than approval in other jurisdictions. We identify any areas of risk with your potential submission and work with you to get appropriate feedback on classification, bench testing, and clinical data requirements
Investigational Testing Authorization (ITA) Preparation
Canada is an excellent location to conduct clinical studies, ranging from first-in-man to multi-center pivotal trials. Data from clinical trials conducted in Canada is generally accepted by the FDA, and the regulatory pathway to initiate studies on novel devices is often more predictable. We have extensive experience obtaining approvals to conduct clinical studies (ITAs) in Canada and can identify the pre-clinical testing necessary to initiate studies.
License ApplicationsClass II-IV
We have more than a decade of experience authoring successful Health Canada License Applications for medical devices ranging from Class II patient monitoring systems to Class IV implantable devices.