SOR/2026-110 Phase 2 Amendments to Establishment Licence Requirements

1. Key takeaways

SOR/2026-110 (Regulations Amending the Medical Devices Regulations (Establishment Licences), P.C. 2026-550) was registered on June 4, 2026, published in the Canada Gazette, Part II on June 17, 2026, and takes effect on December 14, 2026. Three core changes: (1) paragraph 44(4) is replaced, adding an exemption scenario for foreign distributors; (2) section 45 adds supplier information requirements and repeals some information items; (3) documented procedures are elevated from a declaration to an express obligation of the Regulations (sections 52(3), 58, new 58.1, 59(3)(4) and 61.2(4)).

• The amendment was registered and published in mid-2026 and takes effect on December 14, 2026, giving companies a defined window to prepare.
• The new paragraph 44(4)(c) exempts certain foreign distributors that sell through a licensed Canadian importer.
• The application information in section 45 is restructured: new supplier items are added and old items are repealed.
• Five provisions now expressly require documented procedures that are established, implemented and maintained.
• A transitional provision in item 9 covers applications still pending on the coming-into-force date.

2. Legal basis

Because this amendment touches several parts of the establishment licensing scheme at once, the reliable way to read it is item by item. The table below maps each item of SOR/2026-110 to the provisions it changes, together with the registration, publication and coming-into-force dates.

The structure of the amendment matters as much as its content: items 1 to 3 reshape who needs a licence and what must be filed, items 4 to 8 convert procedural expectations into express regulatory duties, and item 9 keeps files that are already in motion from being stranded between the old and new regimes.

3. Expert insights

Insight 1: subparagraph 44(4)(c) is a substantive benefit for foreign distributors, but it is conditional.

The new subparagraph (c) provides that a person who holds an establishment licence is exempt from the verification duty in paragraph 44(3) when importing any devices from a person who is not the manufacturer. The practical effect is that when a foreign distributor sells through a licensed Canadian importer, the foreign distributor no longer needs to hold an MDEL itself. The condition is that its Canadian importer continuously holds a valid MDEL: if the importer’s licence lapses, the exemption falls away with it. Foreign distributors should therefore treat the importer’s licence status as a monitored dependency, not a one-time setup assumption, because the exemption’s validity tracks the importer’s licence in real time.

Insight 2: retailers and health care institutions do not benefit from this exemption.

Under paragraph 44(2), health care institutions and retailers are themselves exempt from the MDEL, but the persons from whom they import must hold an MDEL. A foreign distributor supplying retailers or health care institutions directly therefore still needs to hold an MDEL. This is the scenario most easily misjudged under the new rules: the existence of a general exemption for the Canadian customer does not transfer to the foreign supplier, and the two exemptions operate on different sides of the transaction with no cross-over between them.

Insight 3: documented procedure obligations change from a declaration to an express regulatory requirement.

Under item 5 of SOR/2026-110, section 58 becomes: manufacturers, importers and distributors must each establish, implement and maintain documented procedures that enable them to carry out their activities. New section 58.1 addresses, for Class II to IV devices, the handling, storage, delivery, installation and servicing of devices as well as corrective actions. Sections 59(3)(4) set out procedure duties for preliminary and final reports for Class I and Class II to IV devices respectively, section 61.2(4) sets out procedure duties for the provision of information, and section 52(3) sets out procedure duties for distribution records. The significance is that procedures are no longer something an applicant merely attests to; they are duties the Regulations themselves state, which changes how they will be assessed and evidenced.

Insight 4: paragraph 45(j) is changed to a building-by-building listing.

The amended paragraph 45(j) requires the applicant to list “the address of every building at which the procedures described in sections 52, 58 and 58.1, paragraphs 59(3)(4) and section 61.2(4) are located”. This pairs with the documented procedure duties: at the application stage, the company must already be able to say at which premises each procedure actually runs. The declaration and the physical reality converge into a single, checkable statement.

4. Practical recommendations

• Complete a supply-chain structure assessment before December 14, 2026: determine which foreign entities can use the new exemption.
• Model the scenario of direct supply to retailers or health care institutions separately, since the new exemption does not apply.
• Close the gap on each of the five documented procedures (52(3), 58, 58.1, 59(3)(4), 61.2(4)) and build records showing they operate.
• Prepare the building-address list required by amended paragraph 45(j).
• Handle applications still in process on the effective date under the transitional provision in item 9.

5. Verification checklist

• □ December 14, 2026 is confirmed as the effective date and the remediation plan is scheduled backwards from it
• □ An applicability assessment of the subparagraph 44(4)(c) exemption has been completed
• □ Supply paths to retailers and health care institutions are modelled separately
• □ The five documented procedures are complete and supported by operating records
• □ The building-address list for paragraph 45(j) is prepared
• □ Pending applications are handled under the item 9 transitional provision

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