Licence Holding Structure in Canada: Manufacturer-Held MDL and Importer MDEL

1. Key takeaways

Under the Canadian system, the holder of the MDL is the manufacturer (the official wording is that it is issued to the manufacturer and authorises it to import or sell its own Class II, III or IV devices); the holders of the MDEL are importers, distributors, and Class I manufacturers, whose responsibility is to confirm that devices are licensed or authorised at the time of import or sale, and who bear incident reporting obligations independently. Recall materials may be submitted by the importer on the manufacturer’s behalf under section 65.1.

• Canada has no design of handing the product licence to a local licence holder; the MDL stays with the manufacturer.
• The importer’s duty is “verification plus self-reporting”, not endorsement of the manufacturer’s compliance.
• Under section 44(3), the importer must verify that the party from which it imports holds an MDEL.
• Under section 59(1), the importer submits incident reports independently, in parallel with the manufacturer.
• Section 65.1 permits the importer to prepare and submit recall materials on the manufacturer’s behalf where the content is completely identical.
• Under section 44(4)(b), the verification duty does not apply to anyone importing Class II–IV devices from a manufacturer, which is why foreign manufacturers typically do not need their own MDEL — but a Canadian MDEL-holding importer remains indispensable.

2. Legal basis

The holding structure rests on a small set of provisions that together determine who holds which licence and who verifies whom. The table below lists the provisions and guidance relied on in this article.

3. Expert insights

The holding structure is the first thing a foreign manufacturer should map before designing its Canadian channel, because it determines who carries which legal duty. The insights below separate the duties that belong to each position.

Insight 1: Canada has no design of handing the licence to a local licence holder.

The MDL is held by the manufacturer, consistent with the United States structure where the 510(k) holder is the manufacturer itself. This differs from markets that require licences to be held by local licence holders (such as some arrangements in Thailand and Indonesia). The concern common among Chinese companies that “the licence is taken away by the agent” therefore does not arise in Canada. The flip side is that the manufacturer also carries all product-level obligations itself, without a local holder to share them.

Insight 2: the importer’s duty is “verification plus self-reporting”, not endorsement.

The importer verifies under section 44(3) that the party from which it imports holds an MDEL; it submits incident reports independently under section 59(1); and under GUI-0016 it confirms that devices are licensed or authorised at the time of import or sale. The importer does not carry responsibility for the design and manufacture compliance of the product, but it does carry its own statutory reporting and verification duties. These are personal duties of the importer position, not delegable upwards to the manufacturer.

Insight 3: section 65.1 provides a channel for submitting recall materials on the manufacturer’s behalf.

Under section 65.1, notwithstanding sections 64 and 65, the manufacturer may permit the importer to prepare and submit, on the manufacturer’s behalf, the information and documents related to a recall, on the condition that the information and documents each party must submit are completely identical. Foreign manufacturers can use this provision to agree a division of labour with their Canadian importer, while the underlying reporting obligations remain unchanged.

Insight 4: “foreign manufacturers need no MDEL” and “the importer must hold an MDEL” are a paired conclusion.

Under section 44(4)(b), the verification duty does not apply to anyone who imports Class II–IV devices from a manufacturer — which is why foreign manufacturers typically do not need an MDEL of their own. But the import leg still requires a Canadian party that holds an MDEL. When designing the structure, the Canadian importer should therefore be treated as a mandatory position in the organisation chart, not an optional convenience. A structure that leaves this position vague tends to surface only at the worst possible moment: when goods are already at the border.

4. Practical recommendations

• Record the four positions separately in documentation: MDL holder (manufacturer), MDEL holder, importer, and distributor.
• Have the importer establish a documented process of verifying that devices are licensed before import, and keep the evidence.
• Have the importer establish its incident reporting process independently, without reliance on the manufacturer.
• Document the recall material submission arrangement in writing under section 65.1, and confirm the content is completely identical.
• Design the structure separately for each jurisdiction when running multiple markets in parallel; do not transplant one structure into another.

5. Verification checklist

• □ It has been confirmed that the MDL holder is the manufacturer
• □ The Canadian importer has been identified and its MDEL verified as valid
• □ The importer’s device-is-licensed verification process has been documented and evidenced
• □ The importer has established its incident reporting process independently
• □ The recall material submission arrangement has been documented in writing under section 65.1
• □ Multi-market structures have been designed separately, without transplantation

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