🇦🇺Australia

TGA Non-Compliance Fines for DMR Deficiencies

2 verified sources

Definition

Inadequate DMR control risks TGA audit failures for higher class devices requiring certified QMS and conformity assessment, as DMR holds essential manufacturing specs and QA procedures.

Key Findings

  • Financial Impact: AUD 10,000 - 500,000 civil penalties per breach; 40+ hours per audit remediation[2][7]
  • Frequency: Per TGA audit or adverse event investigation
  • Root Cause: Manual DMR updates without version control or approval workflows

Why This Matters

The Pitch: Medical equipment manufacturers in Australia 🇦🇺 face AUD 20,000+ fines per TGA audit failure on DMR. Automation of DMR control ensures audit-ready compliance.

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

DMR Errors Triggering Warranty Claims

2-5% of revenue in warranty claims and rework; AUD 50,000+ per batch recall[5]

Audit-Triggered Production Halts from DMR Gaps

AUD 5,000 - 20,000 per day production halt; 20-40 hours record retrieval per audit[7]

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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