🇦🇺Australia

Penalties for Using Non-TGA Approved Dental Devices

2 verified sources

Definition

Using non-approved or imported dental devices not on the Australian Register of Therapeutic Goods (ARTG) leads to serious legal, ethical, and financial repercussions including fines and potential deregistration.

Key Findings

  • Financial Impact: AUD 10,000-100,000 fines per violation; inventory write-offs of 5-10% stock value
  • Frequency: Per non-compliant import or use
  • Root Cause: Manual verification failures for overseas materials or components

Why This Matters

The Pitch: Dentists in Australia face AUD 20,000+ fines yearly for TGA non-compliance. Automation of device tracking and ARTG verification prevents violations.

Affected Stakeholders

Dentists, Practice managers, Procurement 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

Fines for Non-Compliance with Dental Regulations

AUD 5,000-50,000 per breach in fines and legal costs; 20-40 hours per audit preparation

Costs from Informed Consent and Record-Keeping Failures

AUD 5,000-30,000 per legal claim or compensation; 10-20 hours per incident documentation

Einnahmeverluste durch abgelehnte oder gekürzte Zahnleistungsansprüche wegen fehlerhafter CDT-Codierung

Quantified: Typischerweise 2–5 % des jährlichen Versicherungsumsatzes als nicht realisierte Erlöse; bei einem Praxisumsatz von AUD 1 Mio. entspricht dies etwa AUD 20.000–50.000 pro Jahr an verlorenen oder gekürzten Erstattungen.

Zahlungsverzug durch Nachforderungen und erneute Einreichung fehlerhaft codierter Zahnleistungsansprüche

Quantified: Typisch 5–10 Stunden Administrationsaufwand pro Monat (ca. AUD 250–600 Lohnkosten) für Nachbearbeitung fehlerhaft codierter Claims plus 10–20 % der Monatsforderungen (z.B. AUD 8.000–30.000) dauerhaft um 2–4 Wochen verzögert, was Zins- und Liquiditätskosten von grob AUD 500–1.500 pro Jahr verursacht.

Versteckte Personalkosten durch manuelle CDT-Codierung und Nachbearbeitung von Zahnversicherungsansprüchen

Quantified: Rund 20–40 Stunden manuelle Codier- und Nachbearbeitungsarbeit pro Monat; bei ca. AUD 30–40 Personalkosten pro Stunde entspricht dies ca. AUD 600–1.600 monatlich bzw. AUD 7.000–19.000 jährlich an vermeidbaren Overhead‑Kosten.

Delayed Lab Billing

30-60 extra AR days x AUD 50k monthly lab spend = AUD 25,000-50,000 opportunity cost

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