🇦🇺Australia

TGA Non-Compliance Fines for Calibration Failures

2 verified sources

Definition

Optometry practices using uncalibrated or poorly logged diagnostic equipment face TGA enforcement for breaching Essential Principles and conformity assessment requirements, including maintenance logging.

Key Findings

  • Financial Impact: AUD 20,240 civil penalty per offence (up to AUD 626,000 for corporations); plus AUD 5,000-10,000 audit remediation costs
  • Frequency: Annual TGA audits or incident-based inspections
  • Root Cause: Manual paper-based or inconsistent digital logging fails traceability requirements per ARGMD guidelines

Why This Matters

The Pitch: Optometry practices in Australia 🇦🇺 risk AUD 20,000+ fines per audit failure on device calibration logging. Automation of logging eliminates this risk.

Affected Stakeholders

Practice owners, Optometrists, Equipment technicians

Deep Analysis (Premium)

Financial Impact

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Current Workarounds

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Get Solutions for This Problem

Full report with actionable solutions

$99$39
  • Solutions for this specific pain
  • Solutions for all 15 industry pains
  • Where to find first clients
  • Pricing & launch costs
Get Solutions Report

Methodology & Sources

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

Evidence Sources:

Related Business Risks

Patient Compensation from Calibration Errors

AUD 2,000-5,000 per patient compensation claim; 5-10% of annual prescription revenue at risk

Excessive Manual Calibration Logging Overhead

20-40 hours/month at AUD 45-60/hour technician rate (AUD 1,000-2,400/month per practice)

Idle Equipment from Logging Bottlenecks

AUD 500-1,000 per day per device (based on 8-12 exams/day at AUD 80-120/exam)

Nicht abgerechnete Kontaktlinsen-Anpassungen und Nachsorge

Quantified: ca. AUD 14.000–28.000 Umsatzverlust pro Praxis und Jahr (1–2 unbezahlte Kontaktlinsen-Konsultationen pro Werktag à ~AUD 60).

Umsatzverlust durch vergriffene Kontaktlinsen-Testlinsen

Quantified: ca. 2–5 % des Kontaktlinsenumsatzes; bei AUD 300.000 CL-Umsatz ≈ AUD 6.000–15.000 entgangener Umsatz pro Jahr durch Stock-outs von Trial- und Standardlinsen.

Überbestände und ablaufende Kontaktlinsenbestände im Lager

Quantified: typischerweise 5–10 % Lagerabschreibung auf Kontaktlinsenbestände; bei AUD 30.000 Lagerwert ≈ AUD 1.500–3.000 direkte Kosten pro Jahr, exklusive Kapitalkosten der Überbestände.

Request Deep Analysis

🇦🇺 Be first to access this market's intelligence