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Device Licence Application — Overview

What is a Device Licence?​

A Device Licence is the market authorisation required to sell Class II, III, and IV medical devices in Canada. It is issued by Health Canada's Medical Devices Directorate (MDD) upon satisfactory review of a manufacturer's application.

The Device Licence is issued to the manufacturer and is specific to a device model or family of devices.

Who must apply​

The manufacturer of a Class II, III, or IV device must apply for a Device Licence before the device can be sold in Canada. This includes:

  • Canadian manufacturers
  • Foreign manufacturers exporting to Canada

Importers and distributors do not hold Device Licences — they hold MDELs. However, they may only import/distribute devices that hold a current Device Licence.

Application submission​

Device Licence applications are submitted electronically via Health Canada's Health Canada e-Submission portal (HRES). All submissions must be in English or French.

Application components​

A complete Device Licence application includes:

1. Administrative information​

  • Manufacturer name, address, and contact details
  • Device name and description
  • Model numbers, catalogue numbers, lot codes
  • Intended use and indications for use
  • Classification justification (with reference to Schedule 2 rules)
  • Device family grouping (if applicable)

2. Safety and Effectiveness Summary​

  • Evidence that the device meets Schedule 1 requirements
  • Benefit-risk analysis
  • Summary of testing performed

3. Labelling​

  • Labels for all components and accessories (English and French)
  • Instructions for Use (English and French)
  • Package inserts (if applicable)

4. Standards compliance​

  • List of applicable standards
  • Mandatory Standards attestation
  • Test reports or certificates of conformity

5. Pre-clinical data​

  • Bench testing, verification, and validation data
  • Biocompatibility evaluation (ISO 10993)
  • Software documentation (IEC 62304, if applicable)
  • Sterility and shelf-life data (if applicable)
  • Electrical safety testing (IEC 60601, if applicable)

6. Clinical evidence (Class III and IV)​

  • Clinical study reports or clinical literature review
  • Summary of clinical evidence
  • Risk management file (ISO 14971)

7. Quality system​

  • MDSAP audit certificate (or equivalent)
  • Manufacturing site information

Review timelines​

ClassTarget review time
Class II15 days
Class III75 days
Class IV300 days

These are target times — complex submissions or those requiring additional information may take longer.

After licensing​

Once a Device Licence is issued:

  • The device is listed in the MDALL database
  • The licence number is assigned and must be referenced in relevant communications
  • Ongoing post-market obligations begin immediately

Legislative source: Medical Devices Regulations, SOR/98-282, ss 32–43 (Device Licence applications)