UAE

The UAE Healthcare Market: A Global Hub for Innovation

Before navigating the regulatory landscape, it is crucial to understand the scale of the UAE medical market. Driven by the « We the UAE 2031 » vision, the country is a global leader in adopting innovative medical technologies and digital health solutions. 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 UAE market. From MOHAP Site Registration, local representation, innovative device pathways, and post-market activities, we deliver end-to-end support tailored to your expansion strategy.

Our Services

The United Arab Emirates is a leading hub for medical innovation in the Middle East. Navigating the Ministry of Health and Prevention (MOHAP) regulations requires a proactive approach to site and product registration. Simon Medtech Solutions streamlines this process to ensure your advanced technologies reach the UAE market efficiently.

Manufacturing Site Registration

Site Registration & Legalization Support. We manage the entire facility registration process, including the complex coordination of document legalization at UAE embassies, ensuring your manufacturing site is approved as a prerequisite for product entry.

Local Authorized Representative & Medical Store

Authorized Representative & Partner Liaison. We assist in selecting and auditing the right local partner. Simon Medtech Solutions acts as your regulatory manager, overseeing the local agent to ensure they fulfill their legal obligations while you maintain control over your brand.

Product Registration & Classification

MOHAP Product Registration Dossier. We handle the classification and the complete electronic filing of your devices. Our experts ensure that your technical data is presented according to UAE standards to achieve rapid approval for both medical devices and IVDs.

Recognition of Global Reference Markets

Fast-Track Regulatory Mapping. We analyze your existing international certifications to leverage the UAE’s recognition pathways. This significantly reduces approval timelines by utilizing your FDA or CE documentation effectively.

Bilingual Labeling & Healthcare Compliance

Localization & Artwork Compliance. We provide specialized medical translation and artwork review services. We ensure your packaging and instructions are 100% compliant with local laws, preventing delays during customs clearance and hospital procurement.

Post-Market Surveillance (Vigilance)

UAE Vigilance & Lifecycle Management. Simon Medtech Solutions manages your post-market obligations. We handle the reporting of adverse events and the coordination of any necessary field safety corrective actions to ensure continued compliance and patient safety.

UAE