Post-Market Surveillance, MDIR Reporting, Annual Reports & Market Actions

ARTG inclusion creates continuing obligations. Sponsors must monitor device safety and performance, manage complaints, report adverse events within the prescribed timeframes, coordinate investigations and market actions, maintain records and respond to TGA post-market requests.

Strengthen Your Australia Post-Market System

When This Support Is Needed

New ARTG inclusion requiring a functioning Australian post-market operating model

Adverse event or near-incident occurring in Australia or overseas involving the device

Safety signal, trend, or recurring complaint cluster identified in global PMS data

Field Safety Corrective Action (FSCA), recall, safety alert, or product correction initiated

Higher-risk device subject to mandatory annual reports for the first three years of inclusion

TGA post-market review, compliance audit, or official Section 41JA information request

What We Challenge Before Submission

Adverse event reportability decision not documented in a defensible audit trail

Manufacturer overseas investigation and Sponsor TGA report contain conflicting conclusions

Overseas recall or safety notice not assessed for impact on Australian ARTG supply

CAPA investigations not closed back into risk management and design history files

Annual report unit-distribution data cannot be reconciled with complaint records

Field corrective action initiated in Australia before Sponsor and TGA strategy is aligned

48 Hours

Public Health Threat

Serious threat to public health requires initial reporting within 48 hours.

10 Days

Death or Serious Deterioration

Events leading to patient death or severe injury reportable within 10 calendar days.

30 Days

Potential Recurrence

Malfunctions that could cause death/injury on recurrence reportable within 30 days.

Our Support Includes

Post-market surveillance (PMS) system review and Australian standard operating procedure setup

Complaint triage and adverse-event reportability assessment

Medical Device Incident Reporting (MDIR) submission via the TGA IRIS database

48-hour serious public health threat reporting management

10-day death or serious deterioration reporting assessment and lodgement

30-day potential recurrence / serious deterioration reporting management

Follow-up investigation coordination and final regulatory report drafting

Statistical trend analysis, signal detection, and risk mitigation review

Manufacturer root-cause investigation and CAPA linkage

Market action / Recall action / PRAC communication and TGA strategy alignment

Overseas regulatory action assessment and mandatory Australian notification

Annual reports authoring for implantable Class IIb, Class III and Class 4 IVDs

Risk management file (ISO 14971) and labelling updates following post-market findings

Response drafting for TGA post-market reviews and regulatory inquiries

Senior Regulatory Question:

Can the Sponsor show a complete evidence trail from the first complaint to the final regulatory and corrective-action decision?

Maintain Rigorous TGA Post-Market Vigilance and MDIR Compliance

Our vigilance experts evaluate reportability, lodge MDIR records in IRIS, and manage TGA recall communications.

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