Health Canada Medical Device Licence (MDL) Application
A Medical Device Licence is required for Class II, III and IV medical devices before they may be imported or sold in Canada. The licence is issued to the manufacturer and is tied to the licensed device or device family/grouping.
Streamlined Application
Generally a more streamlined licence application, but classification, device identifiers, labelling and MDSAP quality-system evidence must still align.
Substantive Review
Requires a substantive pre-market review and a structured IMDRF ToC technical evidence package supporting safety and effectiveness.
Comprehensive Dossier
Highest-risk devices require the most comprehensive evidence package, including detailed safety and effectiveness data and, where applicable, clinical evidence.
Our MDL Support Includes
Expert Focus:
A technically strong dossier is not created by filling every available folder. The evidence must be proportionate to the device class, linked to the safety and effectiveness requirements and presented in a way that allows Health Canada to trace the claim to the supporting data.
File Your Health Canada MDL Application with Confidence
Our regulatory consultants ensure your submission aligns with MDSAP scopes, IMDRF requirements, and Health Canada evidence expectations.