Muhrat Al Marasim
SFDA Statutory Mandate & Legal Representation

Licensed KSA Authorized Representative.

الممثل المعتمد القانوني للأجهزة والمستلزمات الطبية بالمملكة

Safeguard your corporate independence and retain 100% ownership of your Saudi Medical Device Marketing Authorizations (MDMA) with Muhrat Al Marasim's unbundled, sovereign representation.

Diagnose Distributor Lock-in
Regulatory Sovereignty

The strategic necessity of unbundling your AR.

Under the regulations of the Saudi Food and Drug Authority (SFDA), foreign medical device manufacturers without a physical establishment in Saudi Arabia must legally designate a licensed local Authorized Representative (AR).

When you appoint a commercial sales distributor as your AR, they hold the legal title of your MDMA license. Should you ever decide to replace that distributor or appoint a secondary partner, you face protracted legal resistance, administrative blockades, and commercial hostage fees.

Complete separation between legal regulatory custody and commercial sales
Appoint, manage, and replace commercial distributors freely across the Kingdom
Direct agency advocacy with SFDA review committees without third-party bias
Strict non-disclosure agreements (NDAs) protecting sensitive technical files
24/7 Saudi statutory vigilance incident intake and recall coordination
Distributor-Held AR vs. Muhrat Al Marasim
License Legal Custody
• Distributor controls license
• Foreign manufacturer retains 100% control
Distribution Freedom
• Single distributor exclusivity lock-in
• Appoint multiple regional distributors freely
Confidential Technical Data
• Sensitive files exposed to commercial team
• Complete data confidentiality (NDA protected)
License Transfer in Dispute
• Costly delays and legal resistance
• Seamless, immediate cooperation
Post-Market Vigilance
• Secondary to sales goals
• 24/7 dedicated statutory safety triage
Self-Diagnostic Assessment

Saudi Distributor Lock-in Risk Diagnostic

100% Legal Exposure

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.

Execution Workflow

How to Appoint Muhrat Al Marasim as Your Legal AR

01
Mandate Agreement Execution
Bilingual Authorized Representative Mandate drafted in compliance with SFDA requirements.
02
SFDA GHAD System Assignment
Electronic linking of your manufacturer account to Muhrat Al Marasim's verified establishment license.
03
Dossier Screening & Submission
Comprehensive gap audit of technical files and submission for MDMA marketing authorization.
04
Continuous Vigilance & Maintenance
Perpetual license renewal, statutory incident reporting, and unbundled multi-distributor release.

Protect Your Medical Device Marketing Licenses.

Request our standard Authorized Representative Mandate Agreement and fee structure. Our legal directorate will coordinate your transition smoothly.

Contact Legal Directorate