Importers and Distributors under the Canadian Medical Device Rules

1. Key takeaways

According to the definitions in GUI-0016, an importer is a person, other than the manufacturer of the device, located in Canada who is responsible for bringing the device into Canada for sale. A distributor is a person, other than the manufacturer, the importer, or a retailer, who sells medical devices in Canada for the purpose of resale or use other than personal use, and a person outside Canada who sells medical devices into Canada is also considered a distributor. Both importers and distributors must hold an MDEL.

• The importer definition is anchored in Canada: the importer is the entity that brings the device into the country for sale.
• The distributor definition explicitly reaches sellers located outside Canada.
• Importers carry an active verification duty under section 44(3) to ensure their counterparty holds a licence.
• The manufacturer definition turns on selling under one’s own name and taking responsibility, which captures own-brand sellers.

2. Legal basis

The table below lists the instruments relied upon in this article, together with the relevant provisions, dates, and official sources.

3. Expert insights

Insight one: a company selling into Canada from abroad is expressly considered a distributor.

The definition text in GUI-0016 states that “a person outside of Canada selling medical devices into Canada is also considered a distributor”. This means that the argument of being outside Canada and merely selling across the border does not avoid the MDEL requirement. Under the new rules that take effect on 2026-12-14, however, a foreign seller that sells through an importer holding an MDEL may fall within the new exemption described in article 09 of this series. Until the structure that relies on that exemption is confirmed, the default position of a foreign seller is the distributor position, with its attendant obligations.

Insight two: the importer is an entity in Canada, and it carries a verification duty.

Under section 44(3), any person who imports a device must ensure that the person from whom the import is made holds an establishment licence. This is an active verification obligation placed on the importer within the supply chain, not a formality. The importer must therefore operate a real checking step before goods move, and it must be able to show when the check was made and what it covered. An importer that treats the licence check as paperwork done after the fact does not meet the standard that the provision sets. The check should be built into the ordering process itself, so that no purchase order is released until the counterparty’s licence has been confirmed against the official list on that day, and the confirmation record should carry the date and the listing checked.

Insight three: the manufacturer definition centres on selling under one’s own name and taking responsibility.

GUI-0016 quotes the definition of manufacturer in section 1 of the Medical Devices Regulations: a person who sells a medical device under their own name, or under a trade-mark, design, trade name, or other name or mark owned or controlled by them, and who is responsible for designing, manufacturing, assembling, processing, relabelling, repackaging, refurbishing, or modifying the device, or for assigning to it its intended purpose, whether those tasks are performed by that person or on their behalf by another. This definition brings the own-brand seller squarely within the manufacturer scope, and the obligations of a manufacturer follow from the definition rather than from who physically performed the work.

Insight four: a cross-market comparison of roles (practical estimate).

Canada uses the paired roles of importer and distributor, both of which must hold an MDEL. The United States uses a US Agent plus initial importer pairing. The European Union uses the authorised representative, with the label symbol changed from EC REP to EU REP with the publication of EN ISO 15223-1:2021/A1:2025. The United Kingdom uses the UK Responsible Person (UKRP). Thailand and Indonesia use local licence holders or import permit holders. The same company will carry different role names and different obligation scopes in different jurisdictions, so the Canadian framing must not be transplanted to other markets, and each jurisdiction needs its own role comparison table. The table should list, for each jurisdiction, the role names, the licence or registration that attaches to each role, and the reporting duties, so that a group-level compliance plan can be built without assuming that one framework answers for all of them.

4. Practical recommendations

• Determine the role first: responsibility for bringing the device into Canada for sale makes an importer; resale makes a distributor; direct sales from abroad are treated as a distributor.
• Build a written, documented process for the importer to verify before importation that the counterparty holds an MDEL.
• Treat leasing business as a sale, with the same need for an MDEL.
• Assess own-brand sellers as manufacturers, which means they must obtain their own MDL or follow the private labelling pathway (see article 17).
• When operating across markets, build a separate role comparison table for each jurisdiction and never translate the Canadian framework directly into another one.

5. Verification checklist

• □ It has been determined whether the company is an importer, a distributor, or both
• □ If the company sells directly from abroad, it has been confirmed that it is considered a distributor
• □ The importer process for verifying the counterparty’s MDEL has been established and documented
• □ Leasing business has been brought within the MDEL scope as a sale
• □ Own-brand sellers have been assessed under the manufacturer definition
• □ A cross-market role comparison table has been established

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Canadian market. Our team manages Health Canada Medical Device Licence and MDEL applications, prepares risk-classified dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com