Muhrat Al Marasim
Corporate Directorate & History

About Muhrat Al Marasim.

مهرة المراسيم للاستشارات التنظيمية

A legacy of regulatory leadership, uncompromising technical rigor, and sovereign trust in the Saudi Arabian healthcare ecosystem.

Institutional Creed

Transforming compliance into competitive velocity.

At Muhrat Al Marasim (مهرة المراسيم للاستشارات), our core focus is elevating regulatory affairs from an administrative hurdle into a strategic competitive advantage. We work side-by-side with global biomedical engineering teams, pharmaceutical manufacturers, and healthcare innovators to bring transformative diagnostics, therapies, and clinical technologies to Saudi Arabia and the GCC.

Our directorate consists of seasoned biomedical regulatory experts with decades of collective experience with the Saudi Food and Drug Authority (SFDA), GCC Health Council, and international notified bodies.

Institutional Commitments

Sovereign Neutrality
We strictly abstain from commercial product distribution, protecting your marketing licenses from partner conflicts.
Technical Defense
Every dossier is compiled by certified biomedical engineers and medical writers to preempt regulatory deficiency letters.
Unbroken Lifecycle Continuity
Perpetual oversight of renewals, variations, statutory vigilance, and local warehouse audit readiness.
Institutional History

Key Strategic Milestones

2018
Founding in Riyadh
Established by veteran regulatory directors to provide sovereign regulatory advocacy for MedTech innovators entering Saudi Arabia.
2020
GCC Centralized Expansion
Extended cross-border authorization frameworks across UAE MoHAP, NHRA Bahrain, and GCC Health Council centralized mechanisms.
2022
Digital GHAD & UDI Pioneer
Assisted over 180 international medical manufacturers in migrating seamlessly to SFDA GHAD e-submissions and Phase 2/3 GS1 UDI barcoding.
2024
Digital Health & Clinical AI Directorate
Launched dedicated practice group for Software as a Medical Device (SaMD), aligning with SFDA MDS-G015 and Saudi NCA cybersecurity bylaws.
2026
Sovereign Market Access Benchmark
Surpassed 450+ successful marketing authorizations, recognized as the premier independent Authorized Representative in the Middle East.

Partner with Saudi Arabia's Premier Regulatory Institution.

Schedule an initial consultation with our executive directorate to review your company's product registration timeline and authorized representative structure.