🇦🇪UAE

عدم الامتثال لمتطلبات تسجيل المعدات الطبية لدى وزارة الصحة (MOHAP)

5 verified sources

Definition

Medical equipment manufacturers must comply with MOHAP registration requirements under Federal Decree-Law No. 38 of 2024. Registration certificates are valid for 5 years and must be renewed before expiration. Failure to renew or maintain active registration can result in license suspension, precautionary closure, license cancellation, and market access denial. For service contract administration, unregistered or expired registrations prevent legal warranty service delivery.

Key Findings

  • Financial Impact: License revocation + market access denial (unquantified in sources, but typical regulatory penalties in UAE range from AED 10,000–500,000+ depending on violation severity); lost revenue from inability to legally deliver warranty services during renewal gaps
  • Frequency: 5-year renewal cycle; non-compliance discovered during MOHAP audits or customer complaints
  • Root Cause: Manual tracking of 5-year registration renewal deadlines; lack of automated compliance calendars; delayed submission of renewal documentation to MOHAP

Why This Matters

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

Affected Stakeholders

Regulatory Affairs Manager, Warranty Administrator, Product Manager, Quality Assurance Lead

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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

عدم الامتثال لمتطلبات التوثيق الفني والشهادات المطلوبة (eCTD, ISO 13485, شهادة الخلو من الاعتراض)

Estimated 20–40 hours/month of manual document tracking and re-submission efforts per product line; MOHAP audit penalties (not specified in sources, typical range AED 5,000–50,000 for documentation deficiencies); delayed service contract revenue due to registration rejection

خسارة الإيرادات بسبب تأخير معالجة العقود والمطالبات في الضمان

5–15 business days delayed cash per claim × typical claim value (AED 2,000–15,000) × claim volume (assume 20–50 claims/month) = estimated AED 200,000–750,000 annually in delayed cash flow; typical opportunity cost at 7% annual rate = AED 14,000–52,500/year in lost interest or working capital financing cost

قرارات خاطئة في تجديد العقود والتسعير بسبب نقص رؤية البيانات الامتثال

Estimated 2–5% of warranty contract value lost due to pricing errors or non-compliant renewals; typical contract value AED 50,000–200,000/year per device × estimated 20–50 active devices = AED 1M–10M at risk; 2–5% loss = AED 20,000–500,000 annually

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)

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