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Clinical Evidence — What is Required by Class

Overview​

Health Canada requires manufacturers to demonstrate that their devices are safe and effective using appropriate evidence. The level and nature of required clinical evidence varies significantly by device class.

Class I — No pre-market review​

Class I devices do not require a Device Licence and are not reviewed by Health Canada pre-market. No clinical evidence submission is required, but manufacturers must still possess evidence supporting safety and effectiveness as part of their QMS.

Class II — Summary evidence​

Class II devices require a Device Licence but typically do not require original clinical studies. Acceptable evidence includes:

  • Published scientific literature demonstrating safety and effectiveness for the same device type
  • Comparison to a substantially equivalent predicate device already licensed in Canada
  • Post-market clinical data from other jurisdictions (e.g., EU, US, Australia)
  • Technical testing data demonstrating the device performs as intended

Clinical studies are generally not required for Class II devices unless the device is novel or there are specific safety concerns.

Class III — Clinical evidence expected​

Class III devices typically require clinical evidence as part of the Device Licence application. Acceptable evidence:

  • Published clinical studies involving the specific device or substantially equivalent devices
  • Clinical investigation data generated by the manufacturer (may include data from clinical trials conducted in other jurisdictions)
  • Post-market clinical data including registry data, published case series
  • Meta-analyses and systematic reviews

The strength of evidence required depends on the risk profile and novelty of the device. For well-established device types (e.g., standard orthopaedic implants), literature-based evidence is often sufficient. For novel technologies, original clinical data is expected.

Class IV — Comprehensive clinical data​

Class IV devices require the most comprehensive clinical evidence, typically including:

  • Prospective clinical trial data specifically for the device or a closely equivalent device
  • Data from randomised controlled trials (RCTs) where available and appropriate
  • Long-term follow-up data where durability or chronic risks are a concern
  • Post-market data from other jurisdictions where the device has prior regulatory approval

Health Canada may require clinical data generated in Canadian or international populations, depending on whether data from other jurisdictions is considered sufficient.

Clinical evidence summary​

The application must include a Clinical Evidence Summary that:

  • Identifies all clinical evidence considered
  • Critically appraises the quality and relevance of each piece of evidence
  • Draws a conclusion about the overall benefit-risk profile
  • Addresses any gaps in the evidence base

Using a previously approved device as reference​

Where a device has received regulatory approval in a comparable jurisdiction (FDA, EU MDR, TGA), that approval — combined with the evidence used to support it — may be accepted as part of the evidence package for Canada. However, Health Canada conducts its own benefit-risk assessment and is not bound by other regulators' decisions.

Legislative source: Medical Devices Regulations, SOR/98-282, s 32(f); Schedule 1