Device status
Does the intended use bring the software within the Canadian medical-device definition, and which functions form the regulated device?
Health Canada regulatory market
Health Canada licensing for medical device software.
We help SaMD teams assess Canadian device status and classification, prepare MDL and MDEL applications, align MDSAP quality-system evidence and plan the clinical, software and post-market work needed for market entry.
Discuss your market plan →Pathways and services
Regulatory support for Health Canada.
Licence applications
MDL and MDEL application support
Licence-scope assessment, application preparation, supporting records and response support based on the device class and your role in the Canadian supply chain.
Discuss your application →EvidenceClinical evidence strategy
Clinical claims, literature, performance evidence and gap planning proportionate to the Canadian device class.
View service →Use safetyHuman factors and usability
User, environment and use-risk evidence connected to the released interface and risk-management file.
View service →LifecyclePost-market surveillance
Complaint, incident, signal and change processes designed for Canadian reporting and licence maintenance.
View service →What we need to determine
The decisions that shape your application.
Classification
Which Schedule 1 classification rules apply to the software output, clinical purpose and consequence of an incorrect result?
Licence route
Does the product require a Class II, III or IV Medical Device Licence, and does the manufacturer, importer or distributor also require an MDEL?
Quality evidence
Is the manufacturer’s MDSAP certification scope aligned with the legal manufacturer, device activities and licence application?
How we work
From classification to market entry.
- 1
Qualify and classify
Document the intended use, device boundary, Canadian class and applicable regulatory route.
- 2
Assess readiness
Review MDSAP coverage, evidence, labelling, software documentation and post-market processes.
- 3
Prepare the application
Prepare the MDL or MDEL application, supporting records and class-appropriate evidence, then resolve identified gaps.
- 4
Licence and maintain
Support authority questions, then manage changes, incidents, recalls and licence maintenance.
Core regulations, standards and guidance
Food and Drugs ActMedical Devices RegulationsSchedule 1 classification rulesHealth Canada SaMD guidanceMDSAPISO 13485:2016ISO 14971IEC 62304IEC 62366-1
FAQ
Common questions about Health Canada.
Canadian device status, classification, licensing, labelling and MDSAP requirements depend on the product, claims, legal-manufacturer model and supply chain. Confirm current Health Canada requirements for each application.
What is the difference between an MDL and an MDEL?+
A Medical Device Licence is a product licence generally required for Class II, III and IV devices. A Medical Device Establishment Licence authorizes specified establishment activities, including applicable importing and distribution activities and certain Class I manufacturing situations. Depending on the device and supply chain, a business may encounter one or both requirements.
Does every SaMD product need a Medical Device Licence?+
No. Class II, III and IV devices require a Medical Device Licence. Class I devices follow a different model involving establishment-licensing obligations for applicable manufacturers, importers or distributors. Classification and supply-chain roles should be confirmed before filing.
Can an FDA clearance or CE mark be used in Canada?+
Existing FDA or EU evidence can be useful, but it does not replace the Canadian classification and licensing process. Claims, device identifiers, evidence and quality documentation must support the Canadian application.
Is ISO 13485 certification enough?+
For manufacturers of Class II–IV devices, Health Canada generally requires a quality-system certificate issued through MDSAP. An ISO 13485 certificate outside MDSAP does not ordinarily meet that licensing requirement by itself.
Does Canadian labelling need French?+
Canadian medical-device labelling requirements include English and French obligations, with details depending on the information and circumstances. Software interfaces, electronic labelling and accompanying material should be assessed early rather than translated at the end.
Can Predetics guarantee a licence?+
No. Health Canada makes the licensing decision and may request further information. Predetics can improve the quality and coherence of the application but cannot control the authority’s decision or timeline.