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Clinical Trial Pathways in Canada

Overview​

Clinical investigations of medical devices in Canada require Investigational Testing Authorization (ITA) from Health Canada and Research Ethics Board (REB) approval at each participating clinical unlicensed both approval institution. These are parallel, complementary authorizations—both must be obtained before the trial may begin.

Regulatory pathway for device clinical trials​

1. Determine if device is unlicensed (ITA required)
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2. Develop clinical investigation plan (protocol)
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3. Submit ITA application to Health Canada via HRES
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4. Obtain REB approval at each clinical site
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5. ITA issued by Health Canada
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6. Investigation begins (ITA + REB both required)
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7. Report SADEs and protocol amendments to Health Canada
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8. Investigation complete → Clinical study report

GCP requirements​

Clinical investigations in Canada must comply with ICH E6(R2) Good Clinical Practice (GCP) guidelines. Key requirements:

  • Qualified investigators at accredited sites
  • Informed consent process
  • Data integrity and audit trail
  • Independent data monitoring committee (for large/pivotal trials)

Multi-centre trials​

For multi-centre trials with sites across Canada, a single ITA covers all Canadian sites. However, separate REB approval is required at each participating institution.

Using foreign clinical data​

Data from clinical trials conducted outside Canada (US, EU, Australia) may be accepted for Canadian Device Licence applications. See Using Overseas Clinical Data.

Compassionate use during trial​

Where a clinical trial is ongoing but a patient cannot enter the trial (e.g., does not meet eligibility criteria), the Special Access Program may allow compassionate access to the investigational device for that specific patient.

Legislative source: Medical Devices Regulations, SOR/98-282, ss 72–89; ICH E6(R2) GCP

Regulatory pathway for device clinical trials​

"Health Canada typically issues an ITA decision within 30 calendar days of receiving a complete application via HRES. REB approval timelines vary by institution but typically range from 2-8 weeks. The ITA authorization does not take effect until REB approval is confirmed at all participating sites. Applicants should plan for a total timeline of 2-4 months from ITA submission to trial initiation, accounting for both Health Canada review and multi-centre REB coordination."