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Class I · II · III · IV

Class I — Low risk​

Class I devices present minimal potential for harm. They are typically non-invasive, not intended to contact broken skin, and not reliant on a power source.

Examples: bandages, hand-held surgical instruments, crutches, examination gloves (non-sterile), dental floss, tongue depressors, non-powered wheelchairs.

Regulatory requirements:

  • No Device Licence required
  • Importers and distributors must hold an MDEL
  • Must comply with general labelling requirements
  • Must meet Safety and Effectiveness Requirements (Schedule 1) — but no pre-market review by Health Canada

Class II — Low to moderate risk​

Class II devices are non-invasive or minimally invasive with a low to moderate risk profile. Most Class II devices are well-established technologies.

Examples: contact lenses (daily wear), condoms, hearing aids, blood pressure cuffs, surgical masks, CPAP machines, powered wheelchairs, blood lancets.

Regulatory requirements:

  • Device Licence required — submitted to Health Canada
  • Applicant must attest that the device meets Schedule 1 Safety and Effectiveness Requirements
  • Summary of safety and effectiveness data required
  • Compliance with applicable Mandatory Standards must be attested
  • MDSAP audit certificate (or equivalent) required
  • Target review time: 15 days (essentially a completeness check for Class II)

Class III — Moderate to high risk​

Class III devices are typically implantable or life-sustaining with a moderate to high risk profile. They are subject to more extensive pre-market review.

Examples: bone screws and plates, orthopaedic joint replacements, haemodialysers, diagnostic ultrasound systems, IUDs, continuous glucose monitoring systems, arterial catheters.

Regulatory requirements:

  • Device Licence required — with full technical submission
  • Detailed safety and effectiveness evidence (pre-clinical and often clinical)
  • Risk management documentation (ISO 14971)
  • Design verification and validation data
  • MDSAP audit certificate
  • Target review time: 75 days

Class IV — Highest risk​

Class IV devices carry the highest risk and are typically implanted in the heart, used to sustain life, or used as IVDs for life-threatening conditions.

Examples: cardiac pacemakers, ventricular assist devices, deep brain stimulators, total artificial hearts, HIV antibody tests (IVD), hepatitis C tests (IVD).

Regulatory requirements:

  • Device Licence required — most comprehensive submission
  • Full clinical evidence (usually clinical trial data)
  • Comprehensive risk management documentation
  • Manufacturing quality documentation
  • MDSAP audit certificate
  • Target review time: 300 days

Sterile and measuring function implications​

The class of a device may be elevated if the device:

  • Is supplied sterile (sterility adds to risk)
  • Has a measuring function critical to safety (measurement error could cause harm)

These factors are addressed in specific classification rules in Schedule 2.

Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 2; s 2 (definitions)