Canadian medical device registration: MDL / MDEL

Define the scope of this assessment

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.

With ISO 13485, what quality system evidence still needs checking?

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.

Documents must match the products intended for sale

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.

Separate deliverables and costs before quoting

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.

Connecting imports and maintenance after licensing

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

Further reading

• Entering Canada: distinguish MDL, MDEL and commercial channels