📂 SFDA Medical Device Consultancy (Saudi Arabia)

Strategic Regulatory Support for Market Access in Gulf Countries

For companies wishing to sell medical devices in Saudi Arabia and the Gulf region, SFDA (Saudi Food and Drug Authority) approval and registration are mandatory. The SFDA conducts a rigorous registration and evaluation process for both domestic and imported products in terms of quality, safety, and performance.

At Era Management, we manage SFDA-compliant medical device registration processes, enabling you to effectively participate in the Middle East market.

SFDA Consulting Services

  • ›Device Classification and Conformity Assessment
  • ›GHTF recognition structure suitability analysis
  • ›Preparing SFDA Medical Device Marketing Authorization (MDMA) applications.
  • ›Technical File and Certificate Review (ISO 13485, CE, FDA documents)
  • ›Local Representative Service (Authorized Representative)
  • ›eMedical Device System (eMDS) registration support
  • ›Preparation and documentation support prior to SFDA audit.

Why SFDA Consulting?

  • ✓Mandatory registration for exports to Saudi Arabia and GCC countries.
  • ✓Compliance with local representation and language requirements.
  • ✓Matching your CE or FDA certificates with the Saudi system.
  • ✓Fast and effective market entry

✅ Why Era Management?

●International experience in FDA and SFDA applications.
●Device class-specific strategic consulting
●Complete preparation of technical and regulatory documents.
●Comprehensive support in audit and representation processes.
●Industry knowledge encompassing both the manufacturer and distributor sides.

Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

Get More Information

For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

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