SFDA Sector Portal • Muhrat Al Marasim
MedTech, Medical Devices & IVDs.
الأجهزة والمستلزمات الطبية والتشخيصية
End-to-End SFDA MDMA, MDNR Approvals & Technical File Authoring
Regulatory Scope & Architecture
Engineered compliance across the product lifecycle.
Muhrat Al Marasim acts as your regulatory conduit into Saudi Arabia and the GCC for medical devices, in-vitro diagnostics (IVDs), active implantables, and software as a medical device (SaMD). We navigate the rigorous SFDA MDMA classification, Technical Documentation (TFA), risk management (ISO 14971), and post-market surveillance requirements.
SFDA MDMA Marketing Authorization
Turnkey dossier compilation and expedited review management for Class I, IIa, IIb, and III devices through SFDA GHAD portal.
Medical Device National Registry (MDNR)
Mandatory establishment licensing (MDEL) and product listings for low-risk devices and non-sterile accessories.
Authorized Representative (AR) Unbundling
Neutral, licensed Saudi legal representation that frees your brand from local distributor lock-ins.
Technical File & Labelling Conformity
Bilingual English/Arabic labelling, UDI-DI barcoding compliance, and essential principles checklist alignment.
Guaranteed Statutory Deliverables
Official SFDA MDMA Marketing Authorization Certificate
Bilingual IFU and Packaging Artwork Approval
Annual Post-Market Vigilance Representation
Customs Clearance Import Permits
SFDA Filing Readiness Meter
40% ReadySelect 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.