Saudi FDA (SFDA) Medical Device Registration & Technical File Support
Navigate the SFDA's Technical File Assessment route with confidence. Our ISO 13485/14971-aligned documentation ensures your device enters the Saudi market — first time right.
Important: SFDA requirements are built on the same global standards used by FDA, EU MDR, and Health Canada — primarily ISO 13485 and ISO 14971. Our approach leverages your existing quality and risk documentation, avoiding duplication while meeting Saudi-specific requirements.
How We Help You Enter the Saudi Market
The SFDA now enforces a Technical File Assessment (TFA) route for even Class A devices. We guide manufacturers through every step of this process.
Technical File Preparation
We assemble a complete modular dossier keyed to SFDA requirements — design history, manufacturing details, device descriptions, risk reports, test data, and Essential Principles checklist.
- Bill of Materials and process flow documentation
- Biocompatibility and verification records
- GHAD e-submission system formatting and upload
Measuring Function Compliance
Devices with weighing or measuring functions must meet KSA's strict standards for accuracy, repeatability, and environmental testing.
- Stability data aligned with Saudi climate zones
- Calibration protocol validation
Labeling & IFU Localization
We review and prepare all labels, packaging, and instructions to meet SFDA labeling guidance — including bilingual text (English and Arabic for lay-use devices).
- Arabic/English bilingual label templates
- Power, transport, and storage requirement documentation
MDMA Renewal Strategy
We advise on grouping family products to minimize renewal fees and coordinate MDMA renewals. We optimize your portfolio coverage while avoiding redundant submissions.
- Product family grouping analysis
- Renewal timeline and fee optimization
Beyond Saudi Arabia: Global Regulatory Expertise
While we offer deep expertise in SFDA registration, our capabilities extend to every major regulatory jurisdiction. We help manufacturers maintain a single, global Quality Management System while addressing jurisdiction-specific expectations — so you can enter multiple markets without duplicating effort.
Ready to Enter the Saudi Market?
Let us handle the complexity of SFDA registration while you focus on building great medical devices. We make every submission "First-Time Right."
Get Started with SFDA Registration