SFDA: Saudi Food and Drug Authority

Introduction

End-to-end SFDA regulatory expertise for confident market entry

Riar Consulting provides end-to-end regulatory consulting services for companies seeking market entry and compliance with the Saudi Food and Drug Authority (SFDA).

We support manufacturers and distributors across medical devices, IVDs, cosmetics, and other regulated products by aligning technical documentation, regulatory strategy, and submission execution with current SFDA regulations and guidance documents.

Our SFDA team focuses on precision, proper classification, correct application structuring, and proactive query management—ensuring efficient approvals and long-term compliance

OUR EXPERTISE – SFDA

How We Support SFDA Compliance

We assist clients across the full SFDA regulatory lifecycle, including:

  • Product classification and regulatory pathway assessment
  • SFDA Product Classification System (PCS) submissions
  • Medical Device Marketing Authorization (MDMA) applications
  • Authorized Representative (AR) agreement support
  • Importation and Distribution License (MDIL) applications
  • UDI registration in SAUDI-D
  • Cosmetics registration via eCOSMA
  • Renewals, updates, and variations
  • Regulatory query handling and authority communication

Each project is handled through a structured workflow aligned with SFDA’s Medical Device Regulations (MDS), guidance documents, and technical requirements.

WHY RIAR FOR SFDA

Why Choose Riar Consulting for SFDA

  • Strong understanding of SFDA device bundling and classification rules
  • Practical experience handling complex, multi-device portfolios
  • Focus on reducing unnecessary applications and rework
  • Clear documentation mapping aligned with SFDA folder structures
  • High approval success rate through compliant strategy
  • Dedicated SFDA regulatory consultants managing each submission

Our approach minimizes delays, avoids rejection risks, and improves regulatory predictability.

WHO LEADS – SFDA

Dedicated expertise ensuring compliant SFDA approvals

Each SFDA project is led by a dedicated regulatory consultant with hands-on experience in SFDA medical device and cosmetic registrations.

The lead consultant oversees:

  • Regulatory strategy and application structuring
  • Document review and gap assessment
  • Submission execution and follow-ups
  • Client communication and progress reporting

This ensures accountability, clarity, and consistent quality throughout the project lifecycle.

Vision 2030

Simplifying SFDA Compliance With Expert Precision

Let’s collaborate to shape a future where opportunities are limitless.