Complaint Handling and Distribution Record Procedures under SOR/2026-110 in Canada

1. Key takeaways

From 14 December 2026, manufacturers, importers and distributors must each establish, implement and maintain documented procedures covering: distribution records (new section 52(3)), complaint handling and the related procedures (replaced section 58), handling, storage, delivery, installation, servicing and corrective action for Class II–IV devices (new section 58.1), incident reporting procedures (new sections 59(3)(4)), and information provision procedures (new section 61.2(4)).

• The obligation falls on the three parties, each separately: no party can rely on another party’s procedures.
• New section 58.1 lists six activities for Class II–IV devices: handling, storage, delivery, installation, servicing, and corrective action, each “as applicable”.
• The incident reporting procedures are tiered by class: section 59(3) covers Class I, including foreign incidents; section 59(4) covers Class II–IV.
• Section 61.2(4) addresses information provision procedures for MDL holders and importers of Class II–IV devices.
• According to the regulatory impact analysis statement of SOR/2026-110, the procedures are “often missing, have gaps in documentation and implementation, and may be out of date” despite earlier declarations in licence applications.
• The compliance deadline for all five groups of provisions is 2026-12-14.

2. Legal basis

All obligations in this article come from SOR/2026-110, the Regulations Amending the Medical Devices Regulations (establishment licences), read together with the existing provisions of the Medical Devices Regulations. The table below lists each item relied on.

3. Expert insights

The 2026 amendment converts what used to be expectations around licence declarations into express, enforceable procedure obligations. Four points determine how a company should read the new text.

Insight 1: the duty holder is “each of the three parties”, not “any one of them”.

The amended provisions consistently use the formulation “the manufacturer, importer and distributor … must each establish, implement and maintain documented procedures”. None of the three parties can rely on another party’s procedures to satisfy its own duty. A foreign manufacturer cannot point to its importer’s distribution record procedures, and an importer cannot point to the manufacturer’s complaint handling procedures.

Insight 2: new section 58.1 is a complete list of six activities.

New section 58.1 covers, for Class II–IV devices, handling, storage, delivery, installation and servicing, as well as corrective action taken on a device — six activities in total, each qualified by “as applicable”. Companies should confirm applicability activity by activity, and in particular should not drop corrective action from the list simply because it is the last item.

Insight 3: the procedure obligations are tiered by device class.

Section 59(3) targets manufacturers and importers of Class I devices and covers preliminary and final reports under sections 59(1) and (1.1) — that is, including foreign incidents. Section 59(4) targets manufacturers and importers of Class II–IV devices and covers reports under section 59(1). The Class I procedure scope is therefore broader, which is the reverse of how the licence regimes themselves are tiered. Companies holding both Class I and Class II–IV portfolios should keep the two sets of procedures distinguishable so that reviewers can see which tier each document belongs to.

Insight 4: a procedure is no longer compliant by declaration alone.

According to the regulatory impact analysis statement of SOR/2026-110, these documented procedure requirements are “not new and do not impose additional burdens on stakeholders”, but the same statement records inspection findings that, despite declarations made in earlier applications, these procedures are “often missing, have gaps in documentation and implementation, and may be out of date”. This signals that the focus of inspections will shift from whether a declaration exists to whether the procedures actually run. Operating records, not just documents, are what will be examined.

4. Practical recommendations

• Compare existing procedures item by item against the five groups of provisions: 52(3), 58, 58.1, 59(3)(4), and 61.2(4).
• Establish procedures separately for the three parties — manufacturer, importer and distributor — rather than sharing one document.
• Confirm the applicability of each of the six activities in section 58.1, and in particular do not omit corrective action.
• Establish incident reporting procedures separately for Class I and for Class II–IV.
• Leave operating records for every procedure, not only the document itself — the inspection focus is on operation.
• Schedule the remediation work backwards from 2026-12-14, so that the five groups of procedures are complete and running before the provisions come into force.

5. Verification checklist

• □ Procedures for the five groups of provisions have been compared item by item and gaps closed
• □ Procedures have been established separately by the manufacturer, the importer and the distributor
• □ The applicability of the six activities in section 58.1 has been confirmed item by item
• □ Incident reporting procedures have been established separately for Class I and Class II–IV
• □ Operating records exist for every procedure (not only the documents)
• □ Remediation completion has been scheduled before 2026-12-14

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