Post-Market Surveillance, Adverse Events & Recall Support

New Zealand Sponsor Responsibilities Continue After Supply. Medsafe expects sponsors to identify and manage safety issues associated with medical devices supplied in New Zealand. The sponsor should have effective complaint, investigation, adverse-event, distribution-record and recall/corrective-action processes that can operate quickly when a safety concern emerges.

Strengthen Your NZ Post-Market System

When This Support Is Needed

Medical devices, equipment, or IVDs are actively supplied in New Zealand requiring statutory post-market oversight

A serious adverse event, patient injury, or technical malfunction occurs within New Zealand or overseas

A global Field Safety Corrective Action (FSCA), product recall, or customer safety notice affects New Zealand inventory

Medsafe issues a safety inquiry, product alert, or requests root-cause investigation records

What We Challenge Before Submission

Is the incident reportable to Medsafe within the recommended 10 calendar day window for serious injury?

Does a global corrective action or recall notice apply to devices distributed in New Zealand?

Can the sponsor produce complete distribution records showing exactly where affected batches were sent?

Has the device risk management file been updated with newly detected post-market failure modes?

Are field action communications and affected batch/serial traceability completely documented for Medsafe?

Our Post-Market & Recall Support Scope

Post-Market Surveillance (PMS) system and procedure setup aligned with Medsafe guidelines

Customer complaint intake, triage, and adverse event reportability assessment

Initial and final adverse-event reporting to Medsafe (within 10 calendar days for death/serious injury)

Manufacturer-to-Sponsor emergency communication and technical investigation pathways

Root-cause investigation, engineering failure analysis, and CAPA formulation

Periodic Safety Update Reports (PSUR) and Post-Market Clinical Follow-up (PMCF) report authoring

Recall and non-recall corrective action strategy under the New Zealand Recall Code

Field Safety Notice (FSN) drafting for New Zealand healthcare providers and distributors

Distribution-record and affected-customer rapid traceability audits

Assessment of overseas recalls and regulatory safety alerts for New Zealand market impact

Risk management file and labeling updates following post-market safety findings

10-Day Reporting Rule:

For death or serious injury, Medsafe recommends initial reporting as soon as possible and within 10 calendar days. We connect Complaint / Incident -> Investigation -> Risk -> CAPA -> Medsafe Reporting / Recall Action -> Technical Evidence / Labelling Update so post-market information actively drives lifecycle compliance.

Maintain Rigorous Medsafe Post-Market Vigilance and Recall Readiness

Our vigilance team evaluates incident reportability, coordinates Field Safety Notices, and manages regulatory reporting in New Zealand.

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