Saudi Food & Drug Authority (SFDA) Accredited Gateway
Healthcare regulatory excellence in Saudi Arabia.
مهرة المراسيم للاستشارات التنظيمية
Empowering multinational medical device manufacturers and pharmaceutical innovators with independent SFDA Authorized Representation, turnkey MDMA marketing authorizations, and ISO 13485 QMS governance across Saudi Arabia and the GCC.
Select your medical product parameters to compute the mandatory SFDA review pathway, statutory documentation prerequisites, and expected time-to-market.
Turnkey regulatory architectures for Saudi Arabia.
Explore how Muhrat Al Marasim secures compliant market velocity across the Middle East.
Solution Overview
Market Access & Strategic Registration
الوصول إلى الأسواق والتسجيل الاستراتيجي
Achieve compliant, predictable market entry. Muhrat Al Marasim bridges foreign medical manufacturers with national regulators (SFDA, UAE MoHAP, NHRA Bahrain, MoH Kuwait). We engineer the optimal registration pathway to minimize time-to-market while safeguarding intellectual property.
Regulatory Gap Analysis & Roadmap
Thorough pre-submission auditing of technical files, labeling, and clinical data against latest Saudi MDS standards.
Classification Matrix Optimization
Accurately categorizing device risk profiles to prevent over-classification and costly administrative re-reviews.
Direct Agency Advocacy
Dedicated liaison officers managing daily interactions with SFDA review panels and scientific committees.
Post-Approval Lifecycle Maintenance
Continuous change-control oversight, license renewals, and variation filings across multi-year cycles.
Unbundling your legal representation in Saudi Arabia.
SFDA Statutory Custody
100% Sovereign License Ownership
Under Saudi Food and Drug Authority (SFDA) bylaws, the entity holding your Authorized Representative license controls your marketing authorization. Appointing a commercial distributor binds your intellectual property to their commercial terms.
Muhrat Al Marasim provides sovereign, unbundled legal representation. We do not distribute or take commercial margins—ensuring complete license ownership remains with your foreign headquarters.
Answer 3 questions to instantly diagnose whether your medical device intellectual property is at risk of commercial partner lock-in under Saudi law.
1. Who holds the legal mandate of your SFDA Authorized Representative license?
2. Can you appoint secondary regional distributors in KSA without primary distributor consent?
3. If a commercial dispute occurs, does distributor retain statutory authority over customs clearance?
Critical Legal Alert: Severe Distributor Lock-in Detected
Your commercial partner currently has legal leverage over your marketing authorization. If performance drops or you wish to replace them, transfer requires their written consent and payment of compensation. Transition to Muhrat Al Marasim's unbundled AR to reclaim sovereign custody.
Regulatory Knowledgebase
Frequently asked questions.
Direct answers to frequent inquiries regarding SFDA MDMA submissions, authorized representation, and quality compliance.
The Medical Device Marketing Authorization (MDMA) is the official regulatory approval issued by the Saudi Food and Drug Authority (SFDA). It certifies that a medical device or in-vitro diagnostic (IVD) conforms to Saudi technical, safety, and performance standards. No medical device can clear customs or be marketed commercially in the Kingdom of Saudi Arabia without an active MDMA certificate or MDNR listing.
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Schedule an executive briefing with our Senior Regulatory Directorate in Riyadh. We review existing technical dossiers and engineer predictable approval timelines.
