MDEL Exemption for Foreign Manufacturers under Section 44(4)

1. Key takeaways

Under section 44(4) of the Medical Devices Regulations, three situations do not attract the verification duty of section 44(3): (a) a holder of an establishment licence imports Class I devices from a manufacturer; (b) any person imports Class II, III, or IV devices from a manufacturer; and (c) a holder of an establishment licence imports any device from a person who is not the manufacturer, such as a foreign distributor. Item (c) was added by SOR/2026-110 and takes effect on 2026-12-14.

• Item (b) is the long-standing core exemption that lets Class II to IV manufacturers operate without their own MDEL.
• Item (c) extends the same logic to imports from non-manufacturers from the 2026-12-14 effective date.
• The exemptions operate from the importer’s perspective and remove the importer’s verification duty, not the foreign seller’s licence duty in every case.
• Where the importer is a retailer or a health care institution, the foreign supplier must still hold an MDEL.

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: item (b) has been the core exemption for foreign manufacturers for a long time.

The import of Class II, III, or IV devices from a manufacturer by any person does not attract the verification duty of section 44(3), and this item is not conditional on the importer holding an MDEL. This is why foreign manufacturers of Class II to IV devices generally do not need to hold an MDEL themselves: their Canadian importer can import directly from the manufacturer, and the verification duty that would otherwise attach simply does not apply on that importation. The commercial structure of most Canadian market entries has been built on this item.

Insight two: item (c) is the 2026 amendment, extending the same logic to non-manufacturers.

From 2026-12-14, a holder of an establishment licence that imports any device from a person who is not the manufacturer, such as a foreign distributor, also does not attract the verification duty. In other words, a foreign distributor that sells through a Canadian importer holding an MDEL no longer needs to hold an MDEL itself. This closes the gap that previously caught foreign companies whose goods reached Canada through another foreign intermediary rather than directly from the factory, and it aligns the treatment of non-manufacturer supply with the treatment of direct manufacturer supply.

Insight three: the exemption operates from the importer’s perspective, not from the foreign company’s perspective.

The exemption text provides that section 44(3) does not apply, which means the duty removed is the verification duty of the importer. Whether the foreign company itself needs an MDEL depends on whether its Canadian importer satisfies the conditions of the provision. Where the importer is a retailer or a health care institution that is itself exempt from the MDEL under section 44(2), that importer must still verify that the foreign supplier holds an MDEL. The foreign company therefore cannot read its own position from the exemption alone; it must read the position of its counterparty first. A foreign seller with several Canadian customers of different types may sit in different positions at the same time, exempt on some channels and licence-required on others, and the licence duty must be tracked channel by channel rather than decided once for the company as a whole.

Insight four: the transitional provision covers only pending applications.

Under item 9 of SOR/2026-110, the transitional provision addresses establishment licence applications that are still being processed on the effective date. Applications submitted after the effective date fall directly under the new rules, with no carry-over of the earlier treatment. Companies with an application in progress at the effective date should track which regime their file sits under, and companies planning a submission should design the structure for the new rules rather than the old ones, since the window of the previous framework closes on 2026-12-14.

4. Practical recommendations

• Determine the import pathway first: importation from a manufacturer under items (a) or (b), or importation from a non-manufacturer under item (c).
• Application of item (c) is conditional on the importer holding an MDEL, so lock the importer’s licence obligation and its continuing validity into the agreement.
• Where retailers or health care institutions act as importers, the foreign supplier must still hold an MDEL, so the supply chain for such customers must be designed separately.
• Complete the supply chain structure assessment and the corrective work on documented procedures before 2026-12-14.
• Verify the importer’s licence as valid through the MDEL list, which shows only valid MDELs.

5. Verification checklist

• □ The import pathway has been determined as item 44(4)(a), (b), or (c)
• □ If item (c) applies, the importer has been confirmed to hold a valid MDEL
• □ If the importer is a retailer or a health care institution, the foreign supplier has been confirmed to hold an MDEL
• □ The importer’s licence obligation and its continuing validity are locked into the agreement
• □ The structure assessment and procedure corrections are completed before 2026-12-14
• □ The licence status has been verified through the MDEL list

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