Adliya Business Center (ABC) Launches SFDA Medical Device Registration Services
Adliya Business Center (ABC) is proud to announce the launch of its specialized services for medical device registration with the Saudi Food and Drug Authority (SFDA). This initiative aims to simplify the process for manufacturers and distributors seeking market access in Saudi Arabia and ensure compliance with SFDA regulations.
What We Offer
ABC provides comprehensive support for medical device registration, leveraging expertise in regulatory compliance and cutting-edge technology. Our services include:
- Technical File Preparation: Assistance in compiling all required documentation, including device description, risk management files, clinical evaluation reports, and post-market surveillance plans.
- GHAD System Navigation: Expert guidance on using SFDA’s Unified Electronic System for application submission, fee payment, and tracking.
- Regulatory Intelligence: Access to insights on SFDA requirements and updates to ensure smooth approval processes.
- Authorized Representative Services: Support in appointing and registering a Local Authorized Representative (LAR) to represent your company in Saudi Arabia.
Why Choose ABC?
With a team of biomedical engineers and compliance experts, ABC ensures fast-track registration while addressing critical queries efficiently. Our next-generation platform streamlines application preparation, submission, and approval management.
Key Benefits:
- Simplified Process: Navigate complex SFDA regulations effortlessly.
- Fast Approval: Expedite registration through expert gap analysis and document validation.
- Market Compliance: Guarantee adherence to Saudi Arabia’s stringent medical device standards.
How It Works
- Consultation: Discuss your needs with our experts.
- Preparation: Compile required documents such as device description, quality assurance certificates, clinical data, and labeling samples.
- Submission: Submit through the GHAD system with our guidance.
- Approval: Receive your MDMA (Medical Device Marketing Authorization) certificate to market your device in Saudi Arabia.
With ABC’s specialized services, you can ensure that your medical devices meet the stringent requirements of the SFDA, and access the Saudi Arabian market with confidence.
Contact us to book an appointment with one of our experts via ZOOM
