MENA Regulatory Excellence

Empowering Regulatory Success Across MENA

Swift approvals, comprehensive compliance, and expert guidance tailored to your healthcare innovations.

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Since 2012

MENA regulatory partner

3 Offices

Riyadh · Dubai · Cairo

Since 2012

MENA regulatory partner

3 Offices

Riyadh · Dubai · Cairo

Explore MENA footprint →

MRG

Regulatory Services Portal

Medical Regulations Gate · July 25, 2026

Medical Devices Manufacturer

LiveKSA operations

100%

Active module

MDMA — Marketing Authorizations

SFDA marketing authorizations, devices, model codes, new applications & pending updates.

authorizations

Open portal

100%

Active module

MDMA — Marketing Authorizations

SFDA marketing authorizations, devices, model codes, new applications & pending updates.

authorizations

Open portal

506

Total records

5 regulatory modules synced

A single window for your KSA regulatory operations, maintained by MRG.

MRG

Regulatory Services Portal

Medical Regulations Gate

MDMA — Marketing Authorizations

SFDA marketing authorizations, devices, model codes, new applications & pending updates.

270 authorizations

Top global healthcare clients

Track Record

Proven scale across MENA regulatory markets

14+

Years of Experience

1,000+

Manufacturers

60+

National Distributors

400K+

SKU Registrations

Who We Are

Behind MRG: Expertise That Delivers

Trusted regulatory partner since 2012, delivering expert compliance solutions for pharmaceuticals, medical devices, and cosmetics across MENA.

ISO 13485 certified01
Licensed by SFDA, EDE, EDA02

Who We Are

Why MRG

Since 2012MENA footprint

Empowering healthcare innovators to navigate complex regulatory landscapes with confidence.

PharmaceuticalsMedical DevicesCosmetics

Saudi Arabia

Our Services

Comprehensive Sector Services

Regulatory solutions and market access for pharmaceuticals, medical devices, cosmetics, and quality management across the MENA region.

Explore Our Services

01/04

Now featuring

Pharmaceuticals

Comprehensive support for human pharmaceuticals, from initial dossier submission (CTD) to post-market variations and safety monitoring.

CTD dossier submission
Pricing & reimbursement
Post-approval lifecycle

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Medical Devices

Navigating complex risk classifications and ensuring seamless market access for medical equipment, diagnostics, and accessories.

SFDA & MOHAP registration
UDI & establishment licenses
Post-market surveillance

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Cosmetics

Ensuring safety, efficacy, and regulatory alignment for beauty and personal care products entering the MENA region.

Product notification
Labeling compliance
Claims & advertising review

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Quality & Training

Our services are focused on regulated healthcare and life science environments.

ISO & QMS implementation
Regulatory training programs
Audit readiness support

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4 sector services

Why MRG

Why Choose MRG

Partner with MRG for deep regional expertise, proven results, and personalized service. Manufacturers worldwide rely on us for swift regulatory approvals, end-to-end compliance, and ongoing support that unlocks market success.

Why MRG?

Credentials

Delivered through

ISO 13485 Certified

Knowledge Hub

Regulatory Intelligence & Insights

Expert guides on SFDA, EDA, and EDE requirements across pharmaceuticals, medical devices, and cosmetics, curated by MRG consultants.

246 guidesSFDAEDAEDEPharmaDevicesCosmetics

Explore Knowledge Hub

Featured guides

Medical DevicesKSA5 min read

SFDA Authorized Representative in Saudi Arabia: Requirements & How to Appoint One

Foreign manufacturers cannot register or market medical devices in Saudi Arabia without an SFDA-licensed Authorized Representative. Here is what the role covers and how to appoint one…

Saudi ArabiaJul 2026

Read full article Browse all 246 guides

01/04

Now reading

SFDA Authorized Representative in Saudi Arabia: Requirements & How to Appoint One

KSA

Medical Devices

SFDA Authorized Representative in Saudi Arabia: Requirements & How to Appoint One

Foreign manufacturers cannot register or market medical devices in Saudi Arabia without an SFDA-licensed Authorized Representative. Here is what the role covers and how to appoint one…

5 min readSaudi Arabia

Read article

01 / 04

KSA

Pharmaceuticals

SFDA Regulatory Framework for Drug Approval: Pathways, Timelines & Requirements Explained

What the SFDA Regulatory Framework for Drug Approval (Version 6.4) actually covers — the four registration pathways, verification against reference authorities, published review timelines, SDR submission rules, and what applicants are responsible for at every stage…

7 min readSaudi Arabia

Read article

02 / 04

KSA

Pharmaceuticals

Overview of SFDA Regulatory Timelines for Pharmaceuticals and Medical Devices

Type Regular Priority Human Generic 155 93 Human New Drugs registered in SRA 280 168 Human New Drugs not registered…

3 min readSaudi Arabia

Read article

03 / 04

KSA

Medical Devices

Requirements for Medical Devices Marketing Authorization

Download the official Requirements for Medical Devices Marketing Authorization regulatory document.

PDF documentSaudi Arabia

Read article

04 / 04

Testimonials

Voices That Trust MRG

Mindray

Fang Youning

Technical Regulation Department

“It has been an absolute pleasure collaborating with MRG. Their team is highly responsive, professional, and deeply committed to meeting project deadlines. Throughout our engagement, MRG has demonstrated exceptional communication skills and a strong ability to achieve critical goals. They are a reliable partner for addressing our local needs, and we greatly value their contribution to our registration process in Saudi Arabia.”

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Events

Upcoming & Recent Events

Regulatory conferences, exhibitions, and MRG industry participation across the MENA region.

View All

Next EventCountdown to launch

Breaking into KSA Healthcare

28 July 2026Online · Microsoft Teams

--Days

--Hours

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More Upcoming

Pharmaconex

September 2026

Saudi International Medlab Expo

September / October 2026

Recent Highlights

Global Health Exhibition GHE 2025

2025

View Event Details

GHE 2025 – Supply Chain Forum Presentation

2025

View Event Details

Get in Touch

Start Your MENA Regulatory Journey

MRG has three regional offices across Saudi Arabia, the UAE, and Egypt. Talk to an expert or book a local consultation with our team.

Talk to an Expert

Get tailored guidance on SFDA, EDE, and EDA pathways, from first consultation through market approval.

Book a Consultation

Emailinfo@mrg.com.sa Head office+966 11 293 4961

Response within 24 hours

Dedicated regulatory experts on every inquiry

Regional offices

Select a location to view full address and local line.

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Riyadh, Saudi Arabia

Office 409 - 4th Floor, Al Nemar Center Office 1, Building 14, Musa Ibn Nasair Street, No.70 Street, Al Olayah District, Riyadh 12611, Kingdom of Saudi Arabia

Call Riyadh

SFDA · EDE · EDA regulatory coverageMRG DESK