Regulatory Services in Saudi Arabia
MDMA Issuance & Product
Registration (SFDA)
We handle the complete SFDA product registration process, including documentation review, system submission, regulatory validation, and obtaining market authorization for your medical devices in Saudi Arabia.
Process Steps
for MDMA Issuance & Product Registration (SFDA)
Review technical documentation & conformity evidence
Submit product registration request
Respond to SFDA inquiries or clarifications.
Approval and issuance of product registration.
FAQs About MDMA Issuance & Product Registration (SFDA)
How long does it take to obtain MDMA?
It typically takes around 35 working days if the dossier is complete, but timelines may vary depending on product complexity and document readiness.
What is the validity of the MDMA certificate?
The MDMA certificate is valid for 3 years and can be renewed before expiry.
Is medical device registration mandatory in Saudi Arabia?
Yes, all medical devices—including low-risk products—must be registered and obtain MDMA approval before they can be imported or sold in Saudi Arabia.
Which authority is responsible for registration?
The responsible authority is the Saudi Food and Drug Authority (SFDA), which evaluates the safety, quality, and performance of medical devices.
Is CE or FDA approval required?
CE marking is not strictly mandatory, as SFDA allows submission through the Technical File Assessment (TFA) route.
Can multiple products be registered in one application?
Yes, up to 50 products can be registered under one application if they belong to the same group (bundling).
Why to Choose FDRAC
Experienced team
End-to-End solution
Faster market access
Business-focused approach
Transparent pricing
Proven Experience
Our Experts here for your Company
Ensuring your project’s success
Delivering the highest quality and compliance
Working as an extension of your business
This Service Right for You
If you are one of:
International Manufacturers
Looking to register and access the Egyptian market
Local Agents & Distributors
Managing product registration and compliance with EDA
Healthcare & Medical Businesses
Seeking market entry or expansion in Egypt