Canada Licences (MDL & MDEL) — Health Canada Compliance for Medical Devices

Accessing the Canadian Market

To sell medical devices in Canada, manufacturers must comply with the Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act.

Regulatory requirements vary depending on device classification:

Class I Devices

• Require a Medical Device Establishment Licence (MDEL)
• The MDEL must be held by the manufacturer, importer, or distributor

Class II, III, and IV Devices

• Require a Medical Device Licence (MDL) issued by Health Canada
• Additionally require an MDEL for the establishment involved in importation or distribution

Quality System Requirements

All manufacturers and establishments must operate under a Quality Management System compliant with ISO 13485.

Certification under the Medical Device Single Audit Program (MDSAP) is strongly recommended and often required for higher-class devices.

Our Services

ALTRION provides comprehensive regulatory support for market access and ongoing compliance in Canada:

Regulatory Strategy

• Device classification and regulatory pathway definition

Licensing & Registration

• Preparation and submission of MDL applications (Classes II, III, IV)
• MDEL registration for manufacturers, distributors, and importers

Quality & Compliance

• Alignment with ISO 13485 and MDSAP requirements

Post-Market Activities

• License renewals
• Post-market surveillance
• Incident reporting

Representation & Coordination

• Representation for non-Canadian manufacturers
• Direct interface with Health Canada

Our Approach

We support manufacturers at every stage of the Canadian regulatory process — from initial classification and licensing to post-market compliance — ensuring a structured and efficient pathway to market entry.