Product scope and classification
This page covers medical devices and IVDs. Establish product status and risk class from Canadian intended use before discussing licensing. Do not simply reuse Australian or EU classes, or place drugs and natural health products in the MDL/MDEL process.
- State intended use, users, settings and self-test status, and describe body entry and contact duration.
- List models, accessories, software and bundled configurations to avoid a mismatch between licence scope and actual supply.
- Medicines and natural health products follow other product and establishment licensing systems. Determine product status before defining a separate scope.
MDL and MDEL: what does each cover?
An MDL licenses Class II, III and IV medical devices. An MDEL covers specified establishments' manufacturing, importing or distribution activities. Class I devices do not require an MDL, but this does not mean the entire supply chain is exempt from licensing.
- A manufacturer selling its own Class II–IV devices and an independent importer or distributor do not necessarily require the same licences.
- Whether a Class I manufacturer needs an MDEL depends on its customers, supply chain and applicable exemptions.
- List manufacturers, importers, distributors and retailers individually, then check each entity's actual activities.
ISO 13485 and MDSAP
Class II–IV projects must check Health Canada's accepted quality system evidence and MDSAP requirements. An ISO 13485 reference alone does not establish that a certificate is suitable for a Canadian application.
- Do the manufacturer's name, address, production sites and product scope on the certificate match the application?
- Was the certificate issued by a recognised MDSAP auditing organisation, and is its validity and scope suitable?
- Check the quality system scope for manufacturing, and for design and manufacturing, as applicable to Class II and Class III/IV devices respectively.
Product documentation and evidence
Map each model and intended use to its supporting application evidence. Class II and high-risk products require different submission depth; IVDs, software and other products need further detail under applicable guidance.
- Product description, model list, classification rationale and applicable technical, performance and clinical evidence.
- An index of risk management, applicable standards, verification/validation and quality system documents, with versions and gaps.
- Check users and sales settings for labels and IFU. Devices sold to the public require assessment of specified English/French bilingual information; professional-use situations follow their applicable provisions.
- Existing overseas authorizations are checked individually as reference evidence, not treated as automatic Canadian acceptance or approval.
Deliverables and costs
Initial assessment, documentation remediation, application coordination and ongoing maintenance are different stages. Establish the current stage before agreeing deliverables; itemise official fees, audits or testing, translation and third-party professional services separately.
- Pathway memo: product status, proposed class, MDL/MDEL entity relationships and open questions.
- Gap list: missing items, owners, priorities and version requirements.
- Application preparation pack: agreed document index, form coordination and pre-submission check records.
- Project tracker: regulatory questions, owners, response versions and unresolved items.
Importing and licence maintenance
After device licensing, check importer activity licensing, labels, distribution records and complaint/recall coordination. MDEL holders must complete required annual reviews. Changes in licences, products or activities require separate maintenance assessment.
- Use MDALL for device licences and the MDEL database for establishment licences; perform these checks separately.
- Before supply begins, confirm contacts and responsibilities for communicating complaints, adverse events and recalls.
- Licensing does not secure hospital procurement, reimbursement listing or distribution orders. Commercial pathways must continue separately.
Sonictec's scope in Canadian projects
We provide early pathway research, document organisation and project coordination. Before engagement, confirm which work Sonictec undertakes and which requires locally licensed entities, auditing bodies or specialist partners. We do not base commitments on completed Canadian registration cases or an established national channel network.
- Prepare what is needed for decisions, then verify local execution resources.
- Specify applicant, importer and distributor entities, contacts and fees in the engagement scope.
- Unconfirmed resources or evidence will be listed as open issues rather than used to promise submission or approval dates.
Frequently asked questions
Does every company need both an MDL and an MDEL?
MDL and MDEL should not be treated as a compulsory package. An MDL concerns Class II, III and IV device product licensing; an MDEL concerns applicable manufacturing, importing or distribution activities, subject to exemptions. Map the manufacturer, importer, distributor and customers, then assess each entity’s activities. Class I products do not require an MDL, but that does not make the entire supply chain exempt from licensing. Confirming these relationships helps avoid missing requirements or unnecessary applications.
Official sources:Health Canada: MDEL scope, exemptions and ongoing maintenance
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With CE, FDA or TGA documentation, what should we send first?
Provide intended use, a model list, existing overseas authorizations and quality-system certificates, together with the target customer setting and any Canadian partner. Overseas documents help establish the product and available evidence, but their names, scope and relevance to the Canadian application need review. Start with a document inventory and open questions rather than sending all confidential technical material. Detailed certificates and reports can follow once assessment scope and file-sharing arrangements are agreed.
Does Sonictec issue MDSAP certificates?
MDSAP audits and certification are performed by recognized auditing organizations; Sonictec is not a certification body. Canadian Class II–IV projects must address the applicable MDSAP quality-system requirements. The words ISO 13485 alone do not establish compliance. Review the issuer, certificate status, entity and site names, activities and product scope. Sonictec can discuss readiness review and coordination, while the auditing organization is responsible for its audit plan, conclusions and certificate.
Official sources:Health Canada: MDSAP quality system requirements
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Can we start with a Canadian pathway assessment only?
An engagement can start with a defined pathway assessment rather than a full application. Agree the questions to be answered, such as product status and classification, MDL and MDEL responsibilities, quality-system readiness and major evidence gaps, together with written deliverables. Separate confirmed findings from unresolved evidence before committing to testing, remediation or application coordination. Canadian execution resources and applicant entities should be confirmed separately at the appropriate stage, not assumed to be in place.
Can you provide a standard approval timeline and quote?
A useful budget and plan require a defined product and scope. Separate initial assessment, document remediation, application coordination, official charges and external auditing, testing or translation. Distinguish company preparation, third-party work and regulatory processing in the schedule. State start conditions, deliverable milestones, how extra work is charged and unresolved issues. This makes current costs and dependencies understandable even when a final regulatory decision date cannot be fixed in advance.
When do Canadian labels and instructions need English and French?
Do not assume that English-only labelling suits every Canadian sales arrangement simply because the use setting appears similar. Canadian device labelling rules specify language requirements and distinguish sale to the general public from other circumstances. Establish the customer, user and supply route, then assess labels, instructions and required versions. Address language early in registration and channel preparation to avoid discovering packaging or instruction changes only after other documentation is complete.
Official sources:Canada Medical Devices Regulations, section 23: labelling languages
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What ongoing work is needed after MDL and MDEL licensing?
Manage the two licences separately. MDEL holders must address annual review and applicable updates or notifications when entity information or activities change. MDLs require their own product-licence maintenance, change and notification review. Keep separate registers with owners, review points, open actions and current documents. When channel or import partners change, reassess the supply chain rather than relying only on the original grant of a licence.
Official sources:Health Canada: MDEL scope, exemptions and ongoing maintenance ；Health Canada: MDL renewal and right-to-sell fees
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Further reading
Official references
- Health Canada: device classification and licensing
- Health Canada: MDEL scope, exemptions and ongoing maintenance
- Health Canada: MDSAP quality system requirements
- Canada Medical Devices Regulations, section 23: labelling languages
- Health Canada: active device licence search (MDALL)
- Health Canada: MDEL establishment licence search
- Health Canada: medical device import requirements
- Health Canada: device and establishment licensing
Sources checked: 2026-09-15. Assess individual products and projects against current applicable requirements.
