🇦🇺Australia

ARTG Application Delays

3 verified sources

Definition

Full TGA process takes 18-24 months without overseas approvals; Class I: 2 months, Class III: 2-3 months, plus audits for higher classes.

Key Findings

  • Financial Impact: 500-1,000 hours/device at AUD 200/hr (AUD 100,000-200,000 opportunity cost); annual renewal fees AUD 2,220+ per entry
  • Frequency: Per device registration; annual renewals
  • Root Cause: Manual documentation compilation, classification errors, sponsor coordination

Why This Matters

The Pitch: Accessible Hardware Manufacturing wastes 500+ hours/device on TGA submissions. Automation of Technical File review cuts delays by 50%.

Affected Stakeholders

Compliance Officer, Technical Documentation Specialist, Australian Sponsor

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

TGA Non-Compliance Fines

AUD 222,000+ annual ARTG fees per device (based on Class IIb); fines up to AUD 1M per breach; 18-24 months market delay for full conformity assessment

Sponsor Requirement Overhead

AUD 20,000-50,000/year sponsor fees; plus label changes and post-market surveillance hours (200+ hrs/year)

DDA Accessibility Non-Compliance Fines

AUD 20,000 - 100,000+ per lawsuit (legal fees + damages); up to AUD 50,000 court fines

WCAG Certification Rework Costs

AUD 10,000 - 50,000 per product (200+ hours at AUD 100/hr consultant rate)

Lost Sales from Accessibility Churn

2-10% annual revenue loss (AUD 100,000+ for mid-size firm); missed tenders worth AUD 500,000+

Cost of Poor Quality in Compatibility Testing

AUD 72-145M market exposed; 2-5% CoPQ (AUD 1.4-7.2M annually for mid-sized firm) from rework and refunds[1][2][6]

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