Medical Device Licence versus Medical Device Establishment Licence

1. Key takeaways

Canada issues two types of device licence. The Medical Device Licence (MDL) is issued to manufacturers and authorizes them to import or sell their own Class II, III, and IV devices. The Medical Device Establishment Licence (MDEL) is issued to Class I manufacturers and to importers and distributors of devices of every class, licensing them to import or distribute devices. The two licences have different holders and different functions, yet on the supply chain each is the precondition of the other, so a compliant market entry needs both positions filled.

• The MDL holder is the manufacturer; there is no mechanism for a local proxy to hold the product licence.
• The MDEL holder carries the active duty to confirm that a device is licensed or authorized before dealing in it.
• Both licences have annual maintenance actions, on different provisions: the ALR before April 1 for the MDEL and the annual right-to-sell fee for the MDL.
• Manufacturer holds the licence for the product, importer or distributor holds the licence for the entity; both are needed for goods to enter the market lawfully.

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: the holder of the MDL is the manufacturer, not the importer.

The official Health Canada wording is: “A medical device licence (MDL) — a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.” This differs from the market structures in which the licence is placed with a local licence holder. Canada has no design of handing the licence to a Canadian proxy to hold. The foreign manufacturer stands before Health Canada as the licence holder in its own name, and every commercial structure must be built around that fact rather than around a local holding arrangement. Distributor agreements, import contracts, and quality agreements should therefore name the manufacturer as the MDL holder explicitly, so that no party assumes a licence sits somewhere it does not.

Insight two: the core duty of the MDEL holder is to confirm the device is licensed.

According to GUI-0016, an MDEL holder is responsible for confirming that the medical device is licensed or authorized at the time of importation or sale. This is an active verification duty, not a formal checkbox. The holder must have a process that actually checks licence status before goods move, and it must retain evidence of the check. A distributor that ships first and verifies later, or that relies on assurances from trading partners instead of its own verification, does not discharge the duty as the guidance frames it.

Insight three: both licence types have annual maintenance actions.

Under section 46.1(1), an MDEL holder must submit the Annual Licence Review application before April 1 each year. MDL holders must pay the annual right-to-sell fee (460 Canadian dollars, from 2026-04-01). The maintenance actions of the two licences therefore sit on different provisions of the law and follow different mechanics. A calendar that only tracks one of them will let the other lapse, and a lapsed maintenance action is exactly the kind of administrative failure that interrupts an otherwise compliant supply chain. Assigning each line to a named owner, with the provision and the deadline written into the calendar entry, keeps the two maintenance duties from being confused with each other or silently dropped during reorganizations.

Insight four: the binding relationship on the supply chain is a licensed manufacturer plus a licensed importer.

The manufacturer holding an MDL solves the question of whether the product may be placed on the market. The importer or distributor holding an MDEL solves the question of whether the entity may lawfully import and distribute it. If either is missing, the goods cannot lawfully enter the Canadian market, no matter how complete the other side of the arrangement is. Commercial agreements should make both licence positions explicit, because the two licences are examined independently and neither substitutes for the other.

4. Practical recommendations

• Record four positions separately in the documentation: the MDL holder, the MDEL holder, the importer, and the distributor.
• Have the MDEL holder verify the MDL status of the target device before importation and retain the verification records.
• Enter the annual maintenance actions of both licences in the calendar: the ALR (before April 1) and the annual right-to-sell fee.
• For OEM arrangements, confirm the licence status of each factory individually, because the contract manufacturer’s own licence position cannot be covered by the licence position of the commissioning party.
• Verify licence status through both MDALL and the MDEL list, and never rely on third-party paraphrases of licence status.

5. Verification checklist

• □ The MDL holder (the manufacturer) has been determined
• □ The MDEL holder (the importer, distributor, or Class I manufacturer) has been determined
• □ The MDEL holder has a documented process for verifying before importation that the device is licensed, with records retained
• □ The Annual Licence Review (before April 1) has been entered in the calendar
• □ The annual right-to-sell fee (460 Canadian dollars) has been entered in the budget
• □ The licence status of each contract manufacturing site has been verified separately

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