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If you’re planning to launch your product in the Saudi Arabian market, the SFDA (Saudi Food and Drug Authority) plays a critical role in product registration. Whether you deal in pharmaceuticals, food, cosmetics, medical devices, or health supplements, understanding the official requirements is essential for hassle-free market entry. Learn more on Register Products in Saudi Arabia with J K
Who Needs SFDA Product Registration?
You must register your products with the SFDA if you are:
- A manufacturer or distributor of pharmaceutical, food, cosmetic, or healthcare products.
- A foreign exporter planning to sell in Saudi Arabia.
- A local importer or business owner wishing to comply with regulatory standards.
General Requirements for SFDA Product Registration
1. Commercial Registration (CR)
The company importing or distributing the product must hold a valid Commercial Registration in Saudi Arabia with relevant activity codes (e.g., medical, food, cosmetic).
2. Saudi Agent or Legal Representative
Foreign manufacturers must appoint a local Saudi agent or legal representative to handle submissions and communications with SFDA.
3. SFDA Account Creation
Register your company on the SFDA’s online portal depending on the product category (e.g., SADAD, GHTF, or MDMA portals).
Category-Specific Documentation
Food Products
- Product label in Arabic
- Nutritional facts
- Ingredient breakdown
- Manufacturing license
- Free Sale Certificate from country of origin
Cosmetics
- Product formula breakdown
- Packaging and label in Arabic
- Certificate of Analysis (CoA)
- GMP certificate
Medical Devices
- Medical Device Marketing Authorization
- ISO 13485 certificate
- Manufacturer’s Declaration of Conformity
- Instructions for use in Arabic
Pharmaceuticals
- Clinical trial data (if applicable)
- Stability data
- Drug Master File (DMF)
- Good Manufacturing Practice (GMP) certificate
How Long Does Product Registration Take in Saudi Arabia?
The timeframe may vary depending on the product type, completeness of documents, and SFDA category:
- Food/Cosmetics: 2–4 weeks
- Medical Devices/Pharma: 2–6 months
With J K’s expertise, we ensure document readiness, error-free submissions, and follow-up with SFDA, helping you cut down unnecessary delays.
Why Choose J K Management Consultancy?
- End-to-end support
- Arabic label translation & regulatory checks
- Experienced team
- Quick turnaround time
- Trusted by businesses across the UAE & Saudi Arabia
Ready to Apply? Let's Make It Simple
Still wondering what are the requirements to register products in Saudi Arabia? Leave the stress to us.
Contact J K Management Consultancy today and let our specialists handle the entire SFDA product registration process from compliance to final approval.
