Skip to content The Saudi Food and Drug Authority (SFDA) evaluates and approves all food, drugs, cosmetics, and medical devices sold in Saudi Arabia. SFDA registration ensures products meet stringent safety, quality, and labeling standards, protecting public health and fostering trust in local and imported products.
Market Opportunity:
Saudi Arabia represents one of the largest, fastest-growing healthcare and consumer markets in the Gulf region. With over 35 million people and Vision 2030 initiatives, the Kingdom offers substantial opportunities for pharmaceutical, medical device, cosmetic, and food companies. SFDA registration provides gateway access to this lucrative market.
Regulatory Excellence:
The Saudi Food and Drug Authority enforces rigorous safety and quality standards aligned with international best practices, including WHO, FDA, and EMA guidelines. Through proper SFDA product registration, only compliant, safe, high-quality products receive market authorization, protecting consumers while ensuring Saudi regulations meet global benchmarks.
Business Benefits:
SFDA-registered products gain immediate credibility with importers, distributors, healthcare facilities, and retail chains throughout Saudi Arabia. Hospitals, pharmacies, and major retailers require valid SFDA registration certificates before procurement. This authorization facilitates seamless market entry, enhances brand reputation, builds consumer confidence, and establishes sustainable long-term growth.
Our Team of professional advisors will contact you for a tailored package that suits your requirements
Dubai’s food regulations are a framework of laws and standards governing how food is imported, manufactured, labeled, stored, distributed, and sold. The Dubai Municipality is the primary authority responsible for ensuring compliance, supported by the Food Import and Re-export System (FIRS Dubai).
Registration ensures products are free of harmful substances and meet health and safety standards through rigorous testing, quality documentation, and compliance verification protecting public health.
All products must be registered with SFDA before import, sale, or distribution. Non-compliance leads to seizure, withdrawal, legal penalties, and reputational damage.
Only SFDA-registered products can legally enter Saudi retail, healthcare, and e-commerce markets, offering official authorization, brand protection, and smooth import/export operations.
SFDA registration enhances customer trust and credibility for pharmaceutical, medical device, cosmetic, and food brands, signaling stringent international safety standards and building loyalty.
Expert evaluation and classification to determine optimal registration pathway and requirements.
Manufacturing facility assessment and quality system verification for regulatory compliance.
Complete trade facilitation services for seamless market entry and regional expansion.
Strategic consulting for optimal market positioning and distribution channel development.
Products registered and market-ready with optimized timelines based on regulatory pathways
SFDA registration is legally mandatory, ensuring products meet safety, quality, and labeling standards.
SFDA registration applies to all businesses in regulated product trade, distribution, and manufacturing.
Complete registration requires manufacturing licenses, certificates, GMP compliance, labels, studies, clinical data, and documentation.
Comprehensive product evaluation including classification, regulatory pathway determination, compliance assessment, manufacturing facility review, quality systems evaluation, and optimal SFDA submission route determination.
Complete file compilation including technical documentation, GMP certificates, stability studies, clinical data, and Arabic label translations prepared to SFDA standards with authorized representative agreements.
Professional submission through SFDA e-Services portals (GHAD, PCS, FRCS) with complete documentation package, application fee processing, and submission confirmation tracking.
SFDA technical evaluation with active monitoring, query response coordination, and additional documentation submission if required. Review timelines depend on product type.
Coordination with SFDA for GMP inspections, ISO compliance verification, site audits including manufacturing processes, quality control, contamination screening, and facility evaluation.
Certificate issuance, quality assurance review, delivery to client with post-registration support and ongoing compliance guidance. Products officially listed in SFDA database.
The cost varies depending on:
On average, businesses can expect AED 500 – 1,500 per product (excluding government fees and lab testing costs). PRD offers package discounts for multiple SKUs and provides transparent pricing upfront.
98% first-time success rate through precise documentation and compliance checks.
From product classification and safety documentation to SFDA portal submission and labeling.
Dedicated specialists provide real-time updates and answer all your queries.
Trusted by international pharmaceutical, medical device, cosmetic, and food brands expanding regionally.
Clear timelines, no hidden costs, and a smooth process from start to finish.
Proven track record navigating SFDA regulatory pathways with comprehensive expertise across product categories.
Saudi Arabia’s strategic position makes it a gateway to Middle Eastern, African, and Asian markets. With over 35 million residents and robust Vision 2030 healthcare initiatives, demand for quality pharmaceuticals, medical devices, cosmetics, and food products grows exponentially. Navigate the SFDA registration system with expert guidance.
To make sure your product complies, follow SFDA’s safety, labeling, and documentation rules. Each product must meet local testing and manufacturing standards before being accepted for sale.
The SFDA process involves classification, document submission, technical review, and product authroization. It verifies that each item meets Saudi safety and quality benchmarks.
Saudi standards align closely with global benchmarks such as ISO and GMP, but the SFDA adds extra checks for labeling, Arabic documentation, and halal conformity.
Importers must appoint a local representative, maintain valid certificates, and provide full documentation proving the product’s safety, origin, and quality control.
No. Any product in the Kingdom must be registered with the SFDA before importation, sale, or distribution to ensure conformity with national regulations.
Products may include food/cosmetics/pharmaceuticals/medical devices/dietary supplements. Each category follows its own authorization pathway and documentation criteria.
The SFDA monitors compliance through inspections, random sampling, and post-market surveillance to ensure continued safety and product consistency.
Yes. They several electronic systems like GHAD, PCS, and FRCS to handle applications, classification of products, and tracking throughout the authorization cycle.
Product authorization can take from a few weeks to several months depending on the type of product, completeness of the documents, and review complexity.
The requirements include administrative, quality, and safety documents. Applicants must also submit labeling details, testing results, and certifications to complete authorization.
We’re here to help. If you didn’t find the answer you were looking for, feel free to reach out to our team. We’ll make sure you get the clarity you need to move forward with confidence.
Contact us today and transform your product registration journey from challenge to competitive advantage. Your products deserve to reach Saudi Arabia's thriving healthcare and consumer markets.
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