Skip to main content

Guidance Documents — By Device Class

Quick reference to key guidance documents by device class.

Class I​

Class I devices do not require a Device Licence but importers and distributors must hold an MDEL. Key guidance:

  • Guidance on MDEL — who needs an establishment licence, application requirements, QMS expectations
  • Guidance on Labelling — mandatory label content applies to all classes including Class I
  • Guidance on Mandatory Problem Reporting — applies to all regulated parties

Class II​

Class II is the largest category of licensed devices. The target review time is 15 days.

Key guidance:

  • Guidance on Device Licence Applications for Class II Devices — specific guidance on what a complete Class II submission includes
  • Guidance on Attestation to Mandatory Standards — how to attest compliance in the application
  • Guidance on Safety and Effectiveness Summary (Class II) — what level of evidence is expected

Class III​

Class III devices require a more detailed technical review (75-day target). Key guidance:

  • Guidance on Device Licence Applications for Class III and IV Devices — submission requirements
  • Guidance on Clinical Evidence for Class III Devices — level of clinical evidence expected
  • Guidance on Risk Management — ISO 14971 application in the submission context
  • Guidance on Pre-Submission Meetings — useful for novel Class III devices

Class IV​

Class IV devices require the most comprehensive submissions (300-day target). Key guidance:

  • Guidance on Device Licence Applications for Class III and IV Devices
  • Guidance on Clinical Evidence for Class IV Devices — comprehensive clinical data requirements
  • IMDRF MDCE WG N56 — PSUR — periodic safety update report guidance (recommended for Class IV)
  • IMDRF SaMD guidance — if the Class IV device is software-based

IVD-specific guidance​

  • Guidance on the Regulatory Framework for IVD Devices — classification and licensing
  • Guidance on Analytical and Clinical Performance of IVD Devices — performance evaluation
  • Guidance on Point-of-Care and Home-Use IVDs — special requirements for lay-user IVDs
  • Guidance on Companion Diagnostics — regulatory pathway for CDx products
Official source

Health Canada — Guidance Documents for Medical Devices