For periodic renewal of Class C medical device registration (Medical Device Marketing Authorization, MDMA) in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires adherence to specific standards and procedures to maintain the device’s legal marketing status.

Here’s a detailed guide on the standards and step-by-step procedures for renewal:

📌 Standards Applicable to Renewal

1. Compliance with SFDA Regulations

• Renewal must demonstrate ongoing compliance with the latest SFDA Medical Device Regulations, including any updates to:

  • Technical documentation requirements

  • Labeling and instructions for use

  • Post-market surveillance (PMS) obligations

  • Risk management and clinical evaluation

2. Maintenance of Quality Management System

• The manufacturer must maintain a valid ISO 13485 certification throughout the renewal period.

• Evidence of active and effective QMS is required.

3. Updated Technical Documentation

• Technical documentation should be current and reflect any design, manufacturing, or regulatory changes since the last approval.

• Clinical evaluation reports and risk management files must be updated accordingly.

4. Post-Market Surveillance Compliance

• Provide evidence of an ongoing Post-Market Surveillance (PMS) system.

• Submit Periodic Safety Update Reports (PSURs) or equivalent safety data covering the past registration period.

5. Valid Establishment License (EL)

• The manufacturer and the Saudi Authorized Representative must hold valid and active Establishment Licenses during renewal.

🔄 Procedures for Periodic Renewal of Class C Medical Device Registration

Step 1: Initiate Renewal Application Early

• SFDA recommends submitting the renewal application 3 to 6 months before the MDMA certificate expiration to avoid market disruption.

Step 2: Log into the GHAD Portal

• Renewal applications are submitted via SFDA’s GHAD online system:
  https://ghad.sfda.gov.sa

Step 3: Prepare Renewal Documents

• Updated technical file, including:

  • Revised clinical evaluation report

  • Updated risk management file

  • Updated labeling and IFU (if changed)

  • Proof of valid ISO 13485 certification

  • Post-market surveillance reports or PSURs

  • Evidence of compliance with any regulatory updates

• Updated Establishment License copies for manufacturer and Authorized Representative.

Step 4: Submit Renewal Application

• Upload all required documents through the GHAD system.

• Complete all forms accurately and confirm payment of renewal fees.

Step 5: SFDA Review

• SFDA reviews the renewal package, verifying completeness and compliance.

• May request clarifications or additional information.

• Review timeline is typically 1 to 3 months, depending on file quality.

Step 6: Approval and Issuance of Renewal Certificate

• Upon successful review, SFDA issues the renewed MDMA certificate, valid for another 3 years.

• Renewal certificate is accessible via the GHAD portal.

💰 Renewal Fees

• Renewal fees for Class C medical devices generally range between SAR 8,000 to 15,000 (approx. USD 2,100 to 4,000), subject to SFDA fee schedules.

• Fees are payable online during application submission.

⚠️ Important Considerations

• Late renewal can result in suspension or cancellation of the device registration.

• Any significant changes to the device since the last registration may require a new application rather than a simple renewal.

• Maintain continuous communication with your Saudi Authorized Representative to ensure smooth processing.

📑 Summary Table

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