Assess the pathway against the product and research purpose
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
Clarify feasibility and implementation conditions early
Begin with the protocol, local sites, participants, data and timing, then confirm partners, responsibilities and project management.
- 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?
An existing protocol can inform discussions, but regulatory pathways, ethics, sites and data requirements must be verified for Canada.
When should clinical pathway discussions begin?
Initial feasibility discussions can begin once the Canadian target market, research purpose and main evidence gaps are identified.
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.