Saudi Arabia is a key and rapidly growing market in the Middle East for pharmaceuticals, medical devices, and cosmetics, driven by Vision 2030 healthcare investments and increasing demand for high-quality health products.
The Saudi Food and Drug Authority (SFDA) is the primary regulatory body responsible for licensing, manufacturing, importing, exporting, distribution, promotion, and advertising of medicinal products, medical devices, and cosmetics. The SFDA conducts rigorous assessments to ensure only safe, effective, and high-quality products reach the market, issuing marketing authorizations through comprehensive review processes. MedWisdom LifeScience is dedicated to supporting global manufacturers in navigating SFDA requirements, preparing complete submissions, and achieving efficient market entry and sustained compliance in this strategic Middle Eastern market.
Get Saudi Arabia Compliance Support
Complete preparation of CTD dossiers, compilation of required documents (Drug Information File, stability studies, preclinical/clinical data, etc.), and submission to SFDA.
Guidance on Good Manufacturing Practice requirements, gap assessments, audit preparation, and SFDA GMP certification support for manufacturing sites.
End-to-end support for SFDA marketing authorization applications, including new registrations, renewals, and variations for medicinal products.
Management of electronic submissions via SFDA portals, query response preparation, and follow-up throughout the assessment process.
Up-to-date insights into SFDA medical device regulations, classification, and evolving requirements for global manufacturers.
Guidance through the full MDMA (Medical Device Marketing Authorization) and MDNR (Medical Device National Registry) listing process.
Rapid and accurate preparation of responses to SFDA scientific and administrative queries during review for both drugs and devices.
Arabic/English labeling review, SFDA-specific requirements (including artwork, patient information, and packaging), and mock-up approval support.
Classification of cosmetic products, border-line assessments, and regulatory pathway determination per SFDA guidelines.
Ingredient safety checks, formulation compliance with SFDA prohibited/restricted lists, and safety assessment support.
Monitoring of SFDA cosmetic regulations, updates, and best practices for market compliance in Saudi Arabia.
Preparation and submission of cosmetic notifications via the SFDA electronic portal, including all required documentation and follow-up.
Partner with Medwisdom for expert, comprehensive, and compliant regulatory support in Saudi Arabia — from SFDA dossier preparation and submissions to medical device MDMA/MDNR registration, cosmetics notification, and long-term market success.
Contact Our Saudi Arabia Regulatory Experts