🇦🇺Australia
Compliance Penalties
1 verified sources
Definition
Explicit warnings of financial penalties for failing PRAC compliance in medical device recalls.
Key Findings
- Financial Impact: AUD 100,000+ in financial penalties per violation; potential TGA registration revocation
- Frequency: Per non-compliance event
- Root Cause: Bureaucratic delays and unclear prior procedures leading to errors
Why This Matters
The Pitch: Medical equipment firms in Australia face AUD 100,000+ fines annually from recall non-compliance. Automation of PRAC reporting prevents penalties.
Affected Stakeholders
TGA Sponsors, Regulatory Affairs Directors
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.
Related Business Risks
Cost of Poor Quality
AUD 50,000+ per non-compliance incident (fines, legal action); 20-40 hours per recall event on manual steps
Administrative Cost Overrun
AUD 20,000-50,000 per recall in admin costs (20-40 hours/phase at AUD 100/hr)
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.
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