The process for periodic renewal of a Class C medical device SFDA registration in Saudi Arabia involves several key steps to ensure that your device continues to comply with regulatory requirements. Here’s a detailed overview of the renewal procedure:

Periodic Renewal Process for Class C Medical Device SFDA Registration

1. Monitor Renewal Timeline

   • Expiry Date: Track the expiry date of your current SFDA registration. It's crucial to start the renewal process well before the registration expires to avoid any disruption in market access.

2. Prepare Renewal Documentation

   • Updated Technical File: Ensure that the technical file is up-to-date and includes any new data or changes since the last submission. This may include updated clinical data, risk management documents, and manufacturing information.
   • Post-Market Surveillance Report: Include a report on the post-market surveillance activities conducted, including any adverse events and the measures taken to address them.
   • Quality Management System (QMS) Compliance: Verify that your QMS remains compliant with ISO 13485 and include any updates or changes in your documentation.

3. Submit Renewal Application

   • Application Form: Complete the SFDA renewal application form, ensuring all required fields are accurately filled out.
   • GHAD Portal: Submit the renewal application and all required documents through the SFDA’s GHAD (Generic Health and Drug) portal. Ensure that all submissions are complete and meet SFDA requirements.

4. Pay Renewal Fees

   • Fee Payment: Pay the renewal fee as specified by the SFDA. Ensure that the payment is processed and confirmed to avoid any delays in the renewal process.

5. Review and Response

   • SFDA Review: The SFDA will review the renewal application and may request additional information or clarification. Respond promptly to any requests to ensure that the renewal process is not delayed.
   • Documentation Review: Be prepared for potential review of your documentation by SFDA representatives or assessors.

6. Receive Renewal Certificate

   • Approval Notification: Once the renewal application is approved, you will receive a renewed registration certificate from the SFDA. Ensure that you maintain a copy of this certificate and update your records accordingly.

7. Ongoing Compliance

   • Regulatory Updates: Stay informed about any changes in SFDA regulations or requirements that may impact your device. Ensure continued compliance with any new standards or guidelines.
   • Quality Management and Reporting: Continue to adhere to quality management system requirements and keep up with post-market surveillance and reporting obligations.

Key Considerations

• Timely Submission: Start the renewal process early to account for any potential delays or additional requests from the SFDA. It is generally recommended to begin the renewal process at least 3-6 months before the registration expires.
• Accuracy and Completeness: Ensure that all documents and information submitted for renewal are accurate and complete to avoid rejections or delays.
• Communication with Authorized Representative: Coordinate with your Saudi Authorized Representative (AR) to ensure that the renewal process is managed effectively and that all requirements are met.

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