Canada Licences (MDL & MDEL)
Health Canada Compliance
for medical devices
Access the Canadian market with confidence.
Canada Licences (MDL & MDEL)
To sell medical devices in Canada, manufacturers must comply with the Medical Devices Regulations (SOR/98-282)under the Food and Drugs Act.
The regulatory requirements depend on the device class:
- Class I devices: require a Medical Device Establishment Licence (MDEL) held by the manufacturer, importer, or distributor.
- Class II, III, and IV devices: require a Medical Device Licence (MDL) issued by Health Canada, in addition to an MDEL for the establishment involved in distribution or import.
All establishments and manufacturers must operate under a Quality Management System compliant with ISO 13485, preferably certified under the Medical Device Single Audit Program (MDSAP).
ALTRION provides comprehensive support for classification, licensing, renewals, and post-market compliance.
Our Services
- Device classification and definition of the regulatory pathway
- Preparation and submission of MDL applications (Classes II, III, IV)
- MDEL registration for manufacturers, distributors, and importers (Class I and above)
- Allineamento alla conformità ISO 13485 / MDSAP
- License renewal, post-market surveillance, and incident reporting
- Representation for non-Canadian manufacturers
- Direct interface with Health Canada
Why Choose ALTRION
- In-depth knowledge of the die-licensing process and review of MDLs by Health Canada
- Collaboration with qualified Canadian partners and local representatives
- Simplified submission procedures and predictable approval times
- Copertura completa perlicenze di dispositivo e di stabilimento
Results provided
- Validated MDL and/or MDEL licence numbers
- Submission log and official Health Canada communications
- Annual renewal assistance and vigilance reporting
Are you interested in the Canadian market?
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