🇦🇺Australia

TGA CAPA Non-Compliance Fines

2 verified sources

Definition

Inadequate CAPA systems result in TGA non-conformances during audits, triggering fines and product recalls in medical device manufacturing.

Key Findings

  • Financial Impact: AUD 20,000 - 100,000 per TGA enforcement action; 100-500 hours per CAPA audit remediation
  • Frequency: Per audit or adverse event report
  • Root Cause: Manual documentation errors and delayed root cause analysis in CAPA process

Why This Matters

The Pitch: Medical equipment manufacturers in Australia waste AUD 50,000+ annually on CAPA rework and TGA penalties. Automation of CAPA tracking eliminates audit failures.

Affected Stakeholders

Quality Manager, Regulatory Affairs Officer, Manufacturing Director

Deep Analysis (Premium)

Financial Impact

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Current Workarounds

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Methodology & Sources

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

Evidence Sources:

Related Business Risks

Rework from CAPA Delays

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

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.

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.

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.

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