🇦🇺Australia

Administrative Cost Overrun

2 verified sources

Definition

PRAC reduces steps but still requires significant manual effort in documentation and market actions.

Key Findings

  • Financial Impact: AUD 20,000-50,000 per recall in admin costs (20-40 hours/phase at AUD 100/hr)
  • Frequency: Ongoing per recall closure
  • Root Cause: Manual data gathering, portal submissions, and reporting

Why This Matters

The Pitch: Medical equipment manufacturers in Australia incur AUD 20,000-50,000 annually in admin costs per major recall. Automation streamlines phases reducing overhead.

Affected Stakeholders

Market Action Teams, Documentation Staff

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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

Cost of Poor Quality

AUD 50,000+ per non-compliance incident (fines, legal action); 20-40 hours per recall event on manual steps

Compliance Penalties

AUD 100,000+ in financial penalties per violation; potential TGA registration revocation

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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