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What Is the SFDA?
The Saudi Food and Drug Authority (SFDA) is the Kingdom’s chief regulator for food, pharmaceuticals, cosmetics, medical devices, and more. Established in 2003, the SFDA oversees safety, quality, and efficacy standards for all regulated products sold in Saudi Arabia. Learn more on SFDA Registration and Approval Process.
Why the SFDA Registration and Approval Process Matters
To enter the Saudi market, all regulated products medicines, medical devices, food items, cosmetics must pass through the SFDA Registration and Approval Process. This ensures only safe, effective, and high-quality products reach consumers . Skipping or mishandling any step can lead to serious delays or rejection.
SFDA Registration and Approval Process – Step-by-Step
1. Determine Your Product Category
Identify whether your product is a pharmaceutical, medical device, cosmetic, food, or supplement, as each category follows a different approval pathway .
2. Prepare Full Documentation
Include safety data, labeling, manufacturing details, and compliance certificates (e.g., GMP, Free‑Sale Certificate, ISO, UDI, Arabic + English labeling)
3. Appoint a Local Representative
Foreign manufacturers must appoint a Saudi-based representative such as a distributor, MISA licensed entity, or authorized consultant to submit the application on their behalf
4. Submit via SFDA e-Portal
Use the Ghad System (for devices, cosmetics, food) or eSDR (for pharmaceuticals) to submit your dossier and pay applicable fees
5. Validation & Technical Review
- Technical validation: Electronic check for completeness and compliance
- Business validation: Manual review of legal, administrative, and commercial completeness
6. Scientific & Regulatory Assessment
SFDA experts review efficacy, safety, and quality. For pharmaceuticals: testing, inspections, pricing committees, GMP audits; for devices: risk, classification review; for cosmetics and food: standards verification
7. Respond to RFIs
SFDA may issue Requests for Information (RFIs). Prompt responses ensure progress .
8. Final Approval & Certificate
Once satisfied, SFDA issues a marketing authorization certificate, enabling import, sale, and export under Saudi regulations
9. Ongoing Compliance
Maintain compliance by updating registration details, renewing approvals, and promptly reporting changes or adverse events
Timeline & Cost Estimates
- Timelines vary: low-risk products may take a few weeks; pharmaceuticals and high-risk devices typically require several months
- Fees range from minimal (e.g., cosmetics) to substantial (e.g., drug facility registration up to ~$49,000) .
Tips for a Smooth SFDA Registration
- Choose the correct product category and registration pathway
- Prepare complete documentation in English and Arabic
- Respond promptly to RFIs to avoid delays
- Engage an approved Saudi representative for seamless submissions
How J K Management Consultancy Can Help
At J K Management Consultancies, we guide you through every step of the SFDA Registration and Approval Process:
- Product classification and dossier preparation
- Local representation and e-portal submissions
- Technical review, RFI handling, and compliance monitoring
- Lifecyle management—renewals, variations, adverse event reporting
Our goal: Speed up approvals, reduce regulatory risks, and ensure fast, compliant entry into Saudi Arabia.
Ready to Register Your Product?
Let J K Management Consultancies handle your SFDA journey from planning to certification.
Contact us now for a free consultation and accelerate your Saudi market entry
