🇦🇺Australia

TGA Non-Compliance Fines

1 verified sources

Definition

Inadequate warranty and service contract management exposes firms to penalties for non-compliance with medical device safety and traceability.

Key Findings

  • Financial Impact: AUD 222,000 civil penalty per serious breach (TGA maximum)
  • Frequency: Per audit failure
  • Root Cause: Manual record-keeping and reporting delays

Why This Matters

The Pitch: Medical Equipment firms risk AUD 222,000 fines for TGA breaches in contract admin. Automation ensures vigilance reporting compliance.

Affected Stakeholders

Compliance Teams, Quality Assurance

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

Unbilled Service Extensions

2-5% of annual service revenue (AUD 100,000+ for typical firm)

Excessive Contract Variations

AUD 20,000+ per major contract in variation costs (20-40 hours/month manual effort)

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

Bußgelder wegen verspäteter Meldung von Vorkommnissen an die TGA

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.

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.

Request Deep Analysis

🇦🇺 Be first to access this market's intelligence