Saudi Arabia

The Saudi Healthcare Market: A Leading Regional Powerhouse

Before navigating the regulatory landscape, it is crucial to understand the scale of the Saudi medical market. Driven by Saudi Vision 2030, the Kingdom is undergoing a massive transformation, investing billions into a world-class healthcare ecosystem. At Simon Medtech Solutions, we support international manufacturers, software developers, and distributors through every regulatory and operational step required to enter and thrive in the Saudi market. From SFDA Registration, local authorized representation, quality compliance, and GHWP alignment, we deliver end-to-end support tailored to your expansion strategy.

Our Services

The Kingdom of Saudi Arabia represents the largest Medtech market in the Middle East. However, compliance with the Saudi Food and Drug Authority (SFDA) requires rigorous technical preparation. Simon Medtech Solutions provides the local expertise and technical precision to secure your market access.

Establishment Licensing (MDEL)

Establishment Licensing & Compliance Audit. We manage the end-to-end application for your local partners' MDEL, ensuring their facilities and quality systems meet the SFDA’s strict inspection standards.

Saudi Authorized Representative (AR)

Strategic AR Liaison & Representation. We act as your expert intermediary, managing the AR relationship or helping you establish a compliant representation structure to ensure you maintain full control over your product licenses.

Medical Device Marketing Authorization (MDMA)

MDMA Dossier Compilation & Submission. We specialize in drafting and filing MDMA applications. Our team ensures that your GHTF certificates (FDA, CE, etc.) are correctly leveraged to achieve the fastest possible approval via the SFDA’s electronic portal.

GHWP Technical File Alignment

Technical File Optimization. We bridge the gap between your existing technical files and Saudi-specific requirements. We ensure all "Essential Principles" are mapped correctly to prevent the common technical rejections that delay market entry.

Medical Device Identification (UDI)

UDI Implementation & Saudi-DI Management. We manage your product data entry into the Saudi-DI system and provide specific guidance on UDI barcode and labeling compliance to ensure seamless customs clearance.

Post-Market Surveillance (PMS) & Vigilance

Post-Market Vigilance & NCMDR Support. We manage your post-market obligations, from adverse event reporting to Field Safety Corrective Actions (FSCA), ensuring your products remain compliant and your reputation remains protected.