The registration process for Class C medical devices in Saudi Arabia is a structured, multi-step procedure regulated by the Saudi Food and Drug Authority (SFDA) to ensure the safety, efficacy, and quality of medical devices entering the Saudi market.

Here’s a clear breakdown of the key steps involved:

Step 1: Determine Device Classification

• Confirm that your device is classified as Class C based on SFDA’s classification rules.

• Class C devices are medium-to-high risk, e.g., infusion pumps, diagnostic imaging equipment, electrosurgical devices.

Step 2: Appoint a Saudi Authorized Representative (AR)

• If the manufacturer is outside Saudi Arabia, appoint a Saudi-based Authorized Representative.

• The AR must hold a valid Establishment License (EL) issued by SFDA.

• Sign a formal Legal Representation Agreement.

Step 3: Obtain Establishment Licenses (ELs)

• Apply for ELs for both:

  • The manufacturer (or foreign entity)

  • The Authorized Representative

• ELs must be approved before device registration application.

• Application and management of ELs are done through the GHAD system.

Step 4: Prepare Technical Documentation

• Compile a comprehensive technical file including:

  • Device description and specifications

  • Risk management report (ISO 14971)

  • Clinical evaluation report (CER)

  • Declaration of conformity

  • Quality management system certificate (ISO 13485)

  • Labeling and instructions for use (IFU) in Arabic and English

  • Certificates of Free Sale or prior approvals (CE, FDA, etc.)

• Ensure all documents comply with SFDA’s Essential Principles.

Step 5: Register on SFDA’s GHAD Portal

• Both manufacturer and AR must be registered on the GHAD system (https://ghad.sfda.gov.sa).

• The device registration application is submitted through this online portal.

Step 6: Submit the Registration Application

• Submit the application for Class C device registration with all required documentation via GHAD.

• Pay the registration fees (usually SAR 20,000–40,000).

• Provide accurate product details and upload all technical files.

Step 7: SFDA Technical Review

• SFDA conducts a detailed review of the submitted documents.

• May include requests for additional information or clarifications.

• The review timeline typically ranges from 3 to 6 months depending on the completeness and complexity.

Step 8: Response to SFDA Queries

• Respond promptly to any SFDA queries or requests for supplementary documentation.

• Delays in responses may extend the review time.

Step 9: Approval and Issuance of MDMA Certificate

• Upon successful review, SFDA issues the Medical Device Marketing Authorization (MDMA) certificate.

• The certificate is valid for 3 years.

• The approval and certificate can be accessed and downloaded via the GHAD system.

Step 10: Post-Registration Obligations

• Implement post-market surveillance (PMS).

• Maintain compliance with SFDA reporting, labeling, and quality requirements.

• Plan for renewal before expiry.

Summary Table of Steps

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