Associate Partner
Comprehensive regulatory and compliance solutions for Medical Devices in Saudi Arabia (SFDA) and GCC countries – ensuring faster approvals, seamless market access, and sustained post-market compliance.
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Saudi Arabia (SFDA)
MedWisdomLifescience offers comprehensive regulatory support for
medical devices across all risk classes in Saudi Arabia. From
low-risk consumables to high-risk implantable devices, we help
manufacturers achieve SFDA compliance and sustainable market
access.
Saudi Arabia follows a risk-based medical device regulatory
system, aligned with global best practices. Navigating this
framework requires accurate classification, complete technical
documentation, and strategic authority engagement.
Our regulatory expertise covers a wide range of medical devices:
Our regulatory experts ensure submissions meet SFDA expectations from the first review cycle.
Final fees depend on classification, device type, and SFDA fee schedule.
Approx. SAR 10,000 – 25,000 per device
Approx. SAR 5,000 – 10,000
Fees depend on the nature of change
Class C and D devices may take longer due to deeper technical evaluation.
⏱️ 1–2 months
⏱️ 3–6 months
⏱️ Post successful review
MedWisdomLifescience enables confident and compliant medical device market entry in Saudi Arabia.
· Proven expertise in SFDA medical device frameworks
· Strong understanding of risk classification & technical
files
· End-to-end regulatory ownership
· Reduced query cycles and optimized approval timelines
· Long-term post-market compliance support
· Saudi Food and Drug Authority (SFDA)
https://www.sfda.gov.sa/en
· SFDA – Medical Devices Sector
https://www.sfda.gov.sa/en/medical-devices
· SFDA Medical Device Regulations & Guidance
https://www.sfda.gov.sa/en/regulations
End-to-end regulatory services for all classes of medical devices and IVDs in Saudi Arabia (SFDA) and GCC countries – covering pre-registration, registration, and post-approval phases with precision and speed.
Our deep specialization in SFDA and GCC medical device regulations ensures faster approvals, fewer queries, and long-term compliance success.
Fast-track solutions with proactive query minimization and audit-ready documentation.
Unmatched insight into Saudi FDA device pathways and GCC harmonization requirements.
Strong post-market surveillance frameworks and FSCA support for sustained compliance.