Regulatory Services in Saudi Arabia
MDMA Certificate Renewal
& Update Management
We manage renewals and modifications of your MDMA certificates on the SFDA portal, ensuring uninterrupted product availability and regulatory compliance.
Process Steps
for MDMA Certificate Renewal & Update Management
Review the current MDMA certificate and expiration dates.
Prepare updated documentation or technical files.
Submit renewal or update request on the SFDA portal.
Follow up with SFDA reviewers.
Receive updated MDMA certificate.
FAQs
About Authorized
Representation & Product Registration
What is the MDMA Certificate?
The MDMA (Medical Device Marketing Authorization) certificate is an official approval issued by the Saudi Food and Drug Authority (SFDA) that allows medical devices to be marketed and distributed in Saudi Arabia.
What types of devices require MDMA?
All types of medical devices require MDMA, including diagnostic devices, therapeutic devices, surgical instruments, and implantable devices.
When should I start the renewal process for my MDMA certificate?
Start renewal at least 3 months before the expiry date to avoid market interruption.
Can I update product information during the renewal process
yes, updates such as product modifications, new models, or labeling changes can be submitted during renewal.
What happens if my MDMA expires before renewal?
The product cannot be legally marketed or imported until the MDMA is renewed.
Are there fees associated with renewal or updates?
Yes, SFDA charges a fee for renewal and any significant product updates
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