🇦🇺Australia

Bußgelder wegen verspäteter Meldung von Vorkommnissen an die TGA

3 verified sources

Definition

The TGA requires Australian sponsors to submit adverse event reports for medical devices under the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002 using the Medical Device Incident Reporting (MDIR) system, with specified timeframes for different event severities.[1][4] Post‑market vigilance obligations include reporting adverse incidents and other safety information within defined deadlines, supported by the Australian Regulatory Guidelines for Medical Devices (ARGMD) and the Uniform Recall Procedure for Therapeutic Goods (URPTG).[1][4][5] Failure to meet these obligations can lead to regulatory action under the Act, including infringement notices, civil penalties, product suspension or cancellation, and mandated recalls, all of which carry significant financial impact through legal fees, internal remediation, and lost sales.[1][4][5] Because many manufacturers still rely on fragmented, manual complaint-handling systems, reportable events may not be identified or escalated in time, leading to late MDR submissions and heightened TGA scrutiny; each serious compliance failure can reasonably generate six‑figure costs once internal investigation effort, external consultants, legal defence, and disruption from enforced recalls are included (logic based on typical Australian regulatory enforcement economics and the fact that recalls and post-market investigations require extensive resourcing).

Key Findings

  • Financial Impact: Logic-based estimate: AUD 50,000–150,000 per significant late or missed MDR case in combined legal, internal investigation, consultant, and recall-preparation costs; plus risk of additional civil penalties set under the Therapeutic Goods Act 1989.
  • Frequency: Low to medium frequency but high impact; typically associated with clusters of complaints or serious incidents where manual systems fail to flag reportability or deadlines.
  • Root Cause: Manual and siloed complaint handling processes; lack of automated deadline tracking for MDR timeframes; poor integration between customer service, quality, and regulatory functions; inadequate staff training on TGA vigilance rules.

Why This Matters

The Pitch: Medical device manufacturers in Australia 🇦🇺 risk TGA penalties and high recall-management spend easily exceeding AUD 100,000 per serious case due to manual complaint handling and MDR deadline breaches. Automation of complaint intake, coding, and deadline monitoring reduces late reports and avoids enforcement costs.

Affected Stakeholders

Regulatory Affairs Manager, Quality Manager, Post‑Market Surveillance Specialist, Australian Sponsor, Head of Customer/Technical Support

Deep Analysis (Premium)

Financial Impact

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Current Workarounds

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Get Solutions for This Problem

Full report with actionable solutions

$99$39
  • Solutions for this specific pain
  • Solutions for all 15 industry pains
  • Where to find first clients
  • Pricing & launch costs
Get Solutions Report

Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

Überhöhte interne Kosten für manuelle Bearbeitung von Beschwerden und MDR‑Bewertungen

Logic-based estimate: AUD 800–1,800 internal labour cost per escalated or potentially reportable complaint; equating to roughly AUD 120,000–540,000 annually for 150–300 such complaints at a mid‑size manufacturer.

Teure Rückrufe und Korrekturmaßnahmen durch verspätete Trendanalyse von Beschwerden

Logic-based estimate: AUD 200,000–1,000,000 total cost for a large‑scope device recall in Australia triggered late due to poor complaint trend detection (field service, logistics, replacement, and administration).

Kapazitätsverlust durch doppelte Meldungspflichten (Hersteller, Sponsor, Krankenhäuser)

Logic-based estimate: 200–800 specialist hours per year lost to duplicate processing and reconciliation of hospital and sponsor reports, equivalent to roughly AUD 16,000–96,000 annually in staff cost for a mid‑size manufacturer.

Rework from CAPA Delays

AUD 5,000 - 20,000 per major CAPA event in rework costs; 2-5% production scrap increase

TGA CAPA Non-Compliance Fines

AUD 20,000 - 100,000 per TGA enforcement action; 100-500 hours per CAPA audit remediation

Kosten durch mangelhafte Rückverfolgbarkeit in Design History Files

Estimated: AUD 50,000–200,000 per product line over its lifecycle in avoidable verification/validation, test, and engineering rework caused by incomplete or poorly structured DHF traceability.

Request Deep Analysis

🇦🇺 Be first to access this market's intelligence