Digital Health, AI & SaMD.

الصحة الرقمية والذكاء الاصطناعي والبرمجيات الطبية

SaMD Classification, Cybersecurity Conformity & Health Cloud Compliance

Contact Directorate

Regulatory Scope & Architecture

Engineered compliance across the product lifecycle.

Specialized compliance pathways for medical software innovators, telemedicine platforms, wearable diagnostics, and clinical AI models entering the Saudi Health Cloud ecosystem.

SaMD Rule-Based Risk Classification

Determining whether clinical software falls under Class I, II, or III under IMDRF/SFDA algorithms.

Cybersecurity & Patient Privacy Compliance

Alignment with Saudi National Cybersecurity Authority (NCA) essential controls and cloud residency.

Clinical AI Algorithm Validation

Assessment of machine learning training data bias, performance metrics, and clinical utility.

Guaranteed Statutory Deliverables

SFDA SaMD Authorization Certificate

NCA Cybersecurity Conformance Assessment

Health Cloud Interoperability Endorsement

SFDA Filing Readiness Meter

40% Ready

Select the documentation components currently available for your product:

✓

Device / Product Classification & Intended Use Definition

✓

Quality Management System (ISO 13485:2016 or GMP)

Technical Documentation / Dossier (TFA / eCTD)

Bilingual Labelling & Arabic IFU Artwork

Appointed Independent KSA Authorized Representative

Need Direct Technical Guidance?

Our senior directorate will conduct an initial gap analysis of your dossier before statutory filing.

General Contact Office