Research regulatory pathways
Medical device research requires assessment of investigational testing authorization (ITA) and other requirements according to classification and study details. Drug research follows separate clinical trial requirements. Australian CTN/CTA processes cannot simply be transferred to Canada.
- Review of research objectives and existing evidence
- Applicable regulatory and research ethics pathway assessment
- Documentation preparation and local specialist engagement
Local research resources and responsibilities
- Identifying and engaging clinical sites and partners
- Linking clinical evidence to Canadian registration and reimbursement planning
- Define local execution scope and delivery for each project
Frequently asked questions
Can an Australian clinical protocol and process be reused directly?
Australian protocols and clinical evidence can inform Canadian planning, but Australian CTN or CTA processes cannot simply be copied. Canadian device studies require assessment of ITA and other applicable requirements by classification and study purpose, alongside ethics and site approvals; medicines follow a different framework. Compare populations, endpoints, use and execution conditions between the existing and proposed study to identify reusable documents, required additions and responsibility for local implementation.
Official sources:Health Canada: investigational testing authorization guidance for medical devices
Checked:
When should clinical pathway discussions begin?
Clinical feasibility can be discussed once intended use, the Canadian target market and principal evidence gaps are reasonably clear. Provide product information, available clinical or performance evidence, study objectives and desired timing. First determine whether further research is needed and what question it should answer, then investigate local sites, expertise and execution conditions. Sonictec’s initial work can focus on needs assessment and coordination; the Canadian implementation scope must be confirmed for each project.
What can initial Canadian clinical planning deliver?
Clinical planning outputs should address defined evidence questions rather than simply list potential resources. Agree an outline of study objectives and evidence gaps, proposed regulatory and ethics pathways, a document inventory and questions for local sites or specialists. Record sources, assumptions and unresolved conditions so the business can decide on further investment. Execution plans and budgets follow confirmation of partners and scope; an initial planning report is not authorization to conduct a study.
Official references
- Health Canada: investigational testing authorization guidance for medical devices
- Health Canada: drug reviews
Sources checked: 2026-09-15. Assess individual products and projects against current applicable requirements.
