The Saudi Food and Drug Authority

Registration

Unlock the Saudi Market: Expert SFDA Registration Consultancy: Medical Devices

 

Expand your business into the fastest-growing market in the Middle East with confidence. The Saudi Food and Drug Authority (SFDA) mandates strict, high-standard compliance for all imported products. Navigating these complex regulations requires local expertise to prevent costly delays and rejections.

Our dedicated regulatory experts provide end-to-end SFDA registration services, ensuring your Medical Device are compliant and ready for market.

Our 4-Step Process

  1. Initial Assessment & Strategy: We evaluate your product type, classification, and required documents.
  2. Document Preparation & Pre-check: Our experts prepare the dossier and conduct a thorough gap analysis to ensure compliance.
  3. Submission & Regulatory Liaison: We submit the application via the Ghad/SDR system and handle all clarifications with the SFDA.
  4. Approval & Certification: We ensure the final issuance of the SFDA Certificate, allowing you to commence sales in KSA.

Our Comprehensive SFDA Services

We offer a full suite of services tailored to meet your regulatory needs

  • Establishment Registration (EHRS)

    Registering your manufacturing site or company on the SFDA platform.

  • Product Listing & Classification

    Expert classification of products (Medical Devices) to determine the correct regulatory pathway.

  • Dossier Compilation & Review

    Preparing Technical Files, Quality Management System (QMS) documents, and safety studies in line with SFDA guidelines.

  • Authorized Local Agent Support

    Providing authorized, licensed local representation for foreign manufacturers.

  • Label & Artwork Compliance

    Ensuring packaging and labels meet Arabic language, ingredient, and claim requirements.

  • Post-Market Surveillance & Support

    Handling renewals, variations, and compliance updates.

Why Choose Us?

  • Reduced Risk of Rejection: We identify potential gaps in your documentation early.
  • Faster Approval Timelines: Our deep understanding of SFDA guidelines ensures faster processing.
  • Dedicated Support: A focused team manages your project from submission to approval.

Puthiyaveetil, Parampuzha, Kottayam, Kerala – 686004, INDIA

qmserviceindia@gmail.com  |  www.qmserviceindia.com

GSTIN: 32ARTPS8732P2ZP | PAN: ARTPS8732P

Benadict Boby Sebastian  |  CEO

91-9061033526, 91-9349208199, 91-8075108926
email : ceo@qmserviceindia.com