Healthcare Software Regulatory Advisory

Healthcare software regulation in the UAE has moved well beyond basic licensing. With Federal Decree-Law No. 38 of 2024 establishing the Emirates Drug Establishment (EDE) as the federal authority for medical products, Software as a Medical Device (SaMD) now follows a structured classification and approval pathway that demands technical documentation, quality management systems aligned with ISO 13485, and risk management processes under ISO 14971.

For software operating within clinical environments, ADHICS v2.0 mandates 692 cybersecurity controls, NABIDH requires health information exchange interoperability, and the UAE Personal Data Protection Law imposes strict data residency and consent management requirements. Software developers who treat these as afterthoughts face submission rejections, conditional approvals, and costly remediation cycles.

Alpha Health Group provides end-to-end regulatory advisory for healthcare software companies entering or expanding within the UAE and GCC. Our advisory services cover software classification assessment, determining whether your product qualifies as SaMD, clinical decision support, or a general wellness tool, and mapping the corresponding regulatory pathway. We prepare technical documentation packages including quality management evidence, risk assessment reports, clinical evaluation frameworks, and cybersecurity compliance evidence.

Our consultants maintain active working relationships with DOH, DHA, MoHAP, and EDE, providing real-time insight into evolving regulatory expectations, submission best practices, and authority review patterns. Whether your software is a standalone diagnostic algorithm, a patient monitoring application, a clinical workflow automation platform, or an AI-enabled decision support tool, we provide the regulatory intelligence you need to move from development to compliant deployment without unnecessary delays.