2025-08-15 • Official Regulatory Dossier
Interactive Regulatory Intelligence
SFDA Pathway & Approval Timeline Estimator.
Select your medical product parameters to compute the mandatory SFDA review pathway, statutory documentation prerequisites, and expected time-to-market.
Target Review PathwayModerate Complexity
SFDA MDMA Abridged Conformity Assessment (MDS-REQ 1)
Authority: SFDA Medical Device Sector (GHAD Portal)
Estimated Timeline
30 - 60 Working Days
Dossier Model
IMDRF Technical File Assessment ...
Optimization: Capitalize on existing CE/FDA equivalence to reduce official SFDA review duration by 40%.
Mandatory Statutory Requirements:
Full Technical Documentation (TFA) conforming to Saudi MDS-REQ 1
Predicate Comparison & Risk Management File (ISO 14971)
GS1 / Saudi DI UDI Registration & Verification
Sovereign Authorized Representative Mandate Agreement
REGIONAL COVERAGE
Medical Devices
Saudi Arabia • Egypt • UAE • MENA Region
HAAD / DHA / ESMA
United Arab Emirates
Multi-emirate registration
Product Registration & Listings
Product listing with Abu Dhabi Health Authority (HAAD) and Dubai Health Authority (DHA), as well as registering medical products with the Emirates Authority for Standardization and Metrology (ESMA).
Post-Marketing Management
We also manage all post-marketing duties, guaranteeing full compliance and a smooth path to market across the Emirates.
Seamless Market Access
Our support ensures that your products meet all regulatory requirements, achieving compliance and a hassle-free launch across the UAE market.
Regulatory Process Timeline
Select your target market to view the authority-specific registration pathway for Saudi Arabia, the UAE, or Egypt.
United Arab Emirates · HAAD / DHA / ESMA · Multi-emirate registration
1
Multi-Emirate Pathway Assessment1–2 weeks
Define registration strategy across HAAD, DHA, and ESMA requirements and appoint the UAE authorized representative.
2
Technical File & Listing Preparation4–6 weeks
Compile device technical documentation, ISO 13485 certificates, labeling, and Free Sale Certificate for UAE submissions.
3
HAAD / DHA / ESMA Submissions2–4 weeks
File product listings with Abu Dhabi and Dubai health authorities and register with ESMA where applicable.
4
Authority Review & Listing Approval2–5 months
Manage technical queries and deficiency responses until product listing and import authorization are confirmed.
5
Post-Marketing ComplianceOngoing
Handle renewals, variations, adverse event reporting, and ongoing compliance across UAE emirates.
DOCUMENTATION
Required Documents
Select your target market to view the authority-specific documentation required for Saudi Arabia, the UAE, or Egypt.
United Arab Emirates · HAAD / DHA / ESMA
Technical Documentation
- Device description and classification rationale
- Risk management file (ISO 14971)
- Clinical evaluation report
- ISO 13485 certificate and FSC
Authority Submissions
- HAAD product listing application (Abu Dhabi)
- DHA product listing application (Dubai)
- ESMA registration documents (where applicable)
- UAE authorized representative agreement
Labeling & Import
- Device labeling and IFU (Arabic/English)
- Import and distribution authorization
- Emirate-specific clearance documents
- Post-market surveillance plan
Licensed KSA Authorized Representative
Unbundling your legal representation in Saudi Arabia.
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.
Retain 100% intellectual property & marketing license ownership
Appoint, manage, or replace multiple commercial distributors freely
Direct SFDA communication channel without distributor bias
24/7 Saudi statutory vigilance incident reporting
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.
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.
Regulatory Intelligence & Briefings
Latest mandates, SFDA circulars & technical briefs.
Direct regulatory analyses prepared by our senior directors in Riyadh covering classification, QMS certification, and Gulf commercialization.
Start Your Market Entry
Ready to structure your Saudi regulatory pathway?
Schedule an executive briefing with our Senior Regulatory Directorate in Riyadh. We review existing technical dossiers and engineer predictable approval timelines.