RegulinkedThe Ministry of Health (MOH) – Kuwait has issued Ministerial Decree No. (387) of 2025, establishing the regulatory requirements for the registration and circulation of Medical Devices and In Vitro Diagnostic (IVD) devices in Kuwait.
The decree is issued by the Medicine and Medical Products Registration and Regulatory Administration and applies to all medical devices and IVDs intended to be marketed or distributed in Kuwait.
🔍 What’s new:
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Establishes a comprehensive regulatory framework governing medical device and IVD registration, renewal, variation, suspension, cancellation, and agency transfer, applying a single regulatory framework to both Medical Devices and IVDs, with independent risk-based classification requirements.
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Introduces three review application pathways — Standard Review, Fast-Track Review, and Abridged Review — with pathway selection subject to regulatory eligibility and authority discretion, and not granted automatically.
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Defines risk-based classification systems for Medical Devices and IVDs (Class A to Class D), based on intended use and level of risk.
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Formalizes grouping and bundling of medical devices and IVDs under a single application, recognized as an accepted regulatory approach and subject to defined conditions and case-by-case authority assessment.
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Adopts Essential Principles and STED documentation, aligned with the IMDRF framework, as the technical basis for demonstrating device safety, quality, and performance.
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Clarifies requirements for local authorized representatives and confirms acceptance of electronic certificates using approved verification tools.
💡 Why it matters:
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Provides a unified and enforceable regulatory reference for medical device and IVD compliance across the full product lifecycle in Kuwait.
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Clarifies regulatory expectations related to classification, review pathways, technical documentation, and post-market oversight.
📌 How ReguLinked can support you:
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Support interpretation and application of MD (387)/2025 requirements.
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Assist with device classification, pathway selection, and submission readiness.
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Support preparation and review of STED and regulatory documentation in line with Kuwait requirements.
📎 Official PDF: KUW-Medical Device registration requirements
📨 Planning to Submit New, Renewal or Variation application in Kuwait?
Let ReguLinked accelerate your submissions with a fully compliant with Kuwait requirements and strategy.
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