Welcome To RegXComply
Cosmetic Registration in Saudi Arabia — Full SFDA Compliance
RegXComply guides cosmetic brands through the SFDA registration process in Saudi Arabia, ensuring regulatory approvals, labeling compliance, and market access.
Cosmetic registration in Saudi Arabia is essential to ensure product safety, compliance with SFDA regulations, and smooth market entry. RegXComply provides end-to-end solutions, including product assessment, dossier preparation, submission to SFDA, and follow-up. Our services minimize delays, prevent fines, and ensure that your cosmetic products are fully compliant for distribution across the Kingdom.
Understanding the Regulatory Requirements
The Saudi Food and Drug Authority (SFDA) regulates all cosmetic products in KSA.
Key regulatory requirements include:
- Product Composition & Safety: Ingredients must comply with SFDA-approved lists; prohibited substances are strictly banned.
- Labeling Compliance: Labels must contain ingredients, usage instructions, warnings, and Arabic translations, following SFDA guidelines.
- Documentation & Dossier: Full product dossier including safety reports, GMP certificates, ingredient specifications, and product testing results.
- Manufacturing & Import Compliance: Products must be manufactured in GMP-certified facilities. Importers must maintain traceability and compliance records.
- Post-Market Surveillance: SFDA may conduct inspections, request additional data, and monitor products for safety.
Common challenges include incomplete documentation, missing safety certificates, or non-compliant labeling. RegXComply ensures thorough preparation, submission, and ongoing regulatory compliance.
Products Covered
- Skincare, haircare, and personal care
- Makeup & cosmetic products
- Fragrances and perfumes
- Beauty and wellness products
Our Services / How It Works (Expanded):
1.Product Assessment & Gap Analysis
- Evaluate compliance with SFDA regulations
2.Dossier & Documentation Preparation
- Compile safety certificates, GMP documentation, and product specifications
3.Submission & Authority Liaison
- Submit to MOHAP, SFDA, EHA, and other authorities
4.Approval & Compliance Management
- Obtain SFDA registration certificate
- Provide guidance for renewals and post-market compliance
FAQ
Frequently Asked Questions
Who regulates cosmetics in Saudi Arabia?
SFDA (Saudi Food and Drug Authority).
Is cosmetic registration mandatory in KSA?
Yes, for all products sold or imported.
How long does the registration process take?
Typically 3–6 weeks, depending on dossier completeness.
What documents are required?
Safety certificates, GMP documentation, product specifications, and labeling info
Are inspections required?
SFDA may conduct facility or product inspections to ensure compliance.
Work With Us
Register Your Cosmetics in Saudi Arabia with RegXComply
Book a consultation to ensure complete SFDA compliance and expedited approval.
200+
Companies Advised
500+
Product Registered
$25M+
Cost Savings