Accessible Hardware Manufacturing Business Guide
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All 12 Documented Cases
عدم الوضوح في متطلبات التصنيف والتوثيق يؤدي إلى أخطاء في التقديم
AED 5,000–20,000 per misclassified device in unnecessary certifications (e.g., 510K notch filing, EU CE mark when Class I suffices). Multiplied by 5–10 devices in typical portfolio = AED 25,000–200,000 total wasted certification spend. Plus AED 2,000–5,000 rework per incorrect submission.Sources clearly state device classification is a separate 14-day step before 45-day registration. Classification determines whether Class III/IV devices require onsite audits, and which certifications (EC, 510K, PMA) are mandatory. Manufacturers lack clarity on what criteria MOHAP uses to classify, forcing conservative (and expensive) assumptions.
مخاطر إلغاء الترخيص والعقوبات للتوزيع غير المصرح
Potential confiscation of entire inventory (AED 50,000–500,000+ depending on device portfolio value). Legal fines not quantified in sources, but estimated at AED 10,000–100,000 based on MENA regulatory precedent. Market suspension = 100% revenue loss during remediation (weeks to months).Sources emphasize MOHAP registration is mandatory before any sale/distribution ('Before you can start to sell or distribute your medical device in the UAE, it must be registered with MOHAP'). Violation consequences include license suspension, legal liability, and loss of market access. Class III/IV devices are subject to onsite audits, increasing enforcement risk.
تأخير دخول السوق بسبب معالجة التسجيل
AED 30,000–50,000 per device per registration cycle (based on assumed AED 150K–250K annual revenue per SKU; 45/365 days = 12.3% annual revenue loss). Additional loss if competitive entry window closes during delay.The 45 working day MOHAP registration process creates mandatory revenue delay. Companies cannot invoice or deliver until registration is approved. For time-sensitive market opportunities (tenders, seasonal demand, competitive windows), this delay results in lost sales, forfeited contracts, and compressed revenue recognition periods.
تكاليف ممثل مصرح محلي إلزامي وتراخيص التسهيلات
AED 8,000–15,000 annually per LAR entity (estimated: AED 3,000–5,000 LAR licensing + AED 5,000–10,000 PIC salary + facility overhead). Multiplied by number of geographic regions/emirates if separate LARs required.MOHAP requires non-UAE manufacturers to engage an MOHAP-licensed LAR with a dedicated facility and Pharmacist-in-Charge (PIC). Sources indicate 'fees required for this license' and ongoing facility licensing costs. This creates a regulatory moat favoring local companies and increases market entry cost.