🇦🇪UAE

غرامات عدم الامتثال لتتبع الدفعات والأرقام التسلسلية (امتثال UDI)

3 verified sources

Definition

UAE mandates device registration with MOHAP, requiring technical documentation including lot/serial details for traceability under new medical products law. Violations trigger inspections, product seizures, license cancellations, and fines up to AED 1 million per incident[7][5].

Key Findings

  • Financial Impact: AED 1,000,000 maximum fine per violation; AED 100,000+ typical for registration/traceability failures; 5 years license loss blocks AED 5M+ annual revenue[7][4]
  • Frequency: Per violation or annual renewal failure
  • Root Cause: Manual lot/serial tracking errors leading to incomplete MOHAP submissions or post-market traceability gaps

Why This Matters

This pain point represents a significant opportunity for B2B solutions targeting Medical Equipment Manufacturing.

Affected Stakeholders

Regulatory Affairs Manager, Quality Assurance Director, Authorized Representative (MAH)

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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

تكاليف إعادة العمل بسبب فشل تتبع UDI

AED 50,000-200,000 per deferred registration (20-40 hours expert time at AED 2,500/hour + delay costs); typical 2-3 cycles per product[1][4]

فقدان الإيرادات من تأخير تسجيل الأجهزة بسبب مشاكل التتبع

AED 500,000 - 2M per product in lost sales (3-12 month delays at AED 100K/month opportunity cost)

تجاوز التكاليف

40-80 hours/month overtime at AED 200/hr; AED 20,000+ Nafis non-compliance fees.

فقدان السعة الإنتاجية

2-5% capacity loss; AED 100,000/month idle equipment.

فقدان القدرة بسبب CAPA

10% capacity loss (AED 1,000,000+ annually for mid-size firm)

غرامات عدم تسجيل الأجهزة الطبية

AED 20,000-50,000 per deferred registration (consultant fees, 40-80 hours rework); 6-12 months sales delay at AED 100,000+ opportunity cost.

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