Health Canada lists FRM-0360A/FRM-0360B for device recall reporting and shows GUI-0102 GVP guidance issued/implemented May 22, 2026.
Potential impact spans Local Affiliate Compliance, Device Vigilance, Inspection Readiness, Regulatory Intelligence Monitoring, so Local Safety Officer oversight is needed to maintain compliance readiness and evidence traceability.
Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.
Local Safety Officer
Immediate triage (within 1 business day), then weekly review until closure.
Primary-source confirmation recommended before operational implementation.
Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.
Health Canada has pointed industry to specific, named medical device recall reporting forms on its compliance/enforcement pages and has also posted updated metadata for its Good Pharmacovigilance Practices (GVP) guidance.
On Health Canada’s compliance and enforcement “What’s new” page, the regulator lists the “Medical device initial recall reporting form (FRM-0360A)” and the “Medical device final recall reporting form (FRM-0360B),” both dated 2025-05-08. Health Canada’s “Compliance and enforcement of medical devices - Forms, guidance, policies and laws” landing page also links FRM-0360A and FRM-0360B under “Recall reporting for medical devices.”
For pharmacovigilance and device vigilance teams, this creates an immediate document-control checkpoint. Any company conducting medical device recalls in Canada (including manufacturers, importers, and distributors that submit recall reports) should confirm that internal controlled templates, working instructions, and recall checklists reference the correct form IDs (FRM-0360A for initial reporting and FRM-0360B for final reporting) and align with the fields on the currently posted forms.
Separately, Health Canada’s “Good pharmacovigilance practices guidelines (GUI-0102)” page indicates the guidance was issued May 22, 2026 and implemented May 22, 2026. The page also states that this version replaces the prior GUI-0102 implemented August 11, 2013. While the fact pattern available here is limited to the issuance/implementation metadata and replacement statement, the change is relevant to drug manufacturers/market authorization holders subject to Health Canada GVP inspections.
In practical terms, PV Quality and inspection-readiness teams may want to treat the May 22, 2026 GUI-0102 as the current Health Canada GVP reference point and perform a targeted gap assessment versus existing Canada PV SOPs and inspection-readiness materials, especially where content is explicitly framed around regulator expectations.
Operationally, teams should avoid assuming the nature of changes within FRM-0360A/FRM-0360B or within the GUI-0102 guidance itself without reviewing the currently posted documents and comparing to any prior controlled versions in their quality systems.
For next steps, PV Quality Leads—supported by Medical Device Vigilance Leads and Regulatory Intelligence—can (1) download FRM-0360A and FRM-0360B from Health Canada and confirm internal template libraries and recall workflow tooling reference the correct form IDs and required fields, and (2) retrieve the May 22, 2026 GUI-0102 and log any needed process/document updates via CAPA after a targeted gap check for Canada inspection readiness.
This is a near-term readiness item for Canada operations ahead of the next recall submission or Health Canada interaction, with ongoing monitoring of Health Canada compliance/enforcement postings and GUI-0102 updates as part of routine regulatory intelligence review.
Review and update labeling processes in accordance with the newly published safety-related changes for affected products.
MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.
Implementation of new dosing schedules and an emphasis on monitoring for potential adverse reactions as outlined in the prescribing information.
Regulatory compliance processes may need updates to incorporate the new recombinant endotoxins testing method and guidelines established under the ICMRA framework.
