The Class C medical device registration process with the Saudi Food and Drug Authority (SFDA) in Saudi Arabia involves several key steps. Here’s a comprehensive guide to the process:

Steps for Class C Medical Device SFDA Registration

1. Preparation and Planning

   • Understand Requirements: Familiarize yourself with SFDA regulations and guidelines specific to Class C medical devices.
   • Appoint Authorized Representative (AR): Select and appoint a qualified Saudi Authorized Representative, if you do not have a local presence in Saudi Arabia. The AR will handle the registration process on your behalf.

2. Gather and Prepare Documentation

   • Technical File: Prepare a comprehensive technical file including:
     • Device description and intended use
     • Design and manufacturing information
     • Risk management documentation (ISO 14971)
     • Clinical evaluation report
     • Testing reports (e.g., safety, performance, biocompatibility)
   • Quality Management System (QMS): Ensure compliance with ISO 13485 and include documentation of your QMS.
   • Labeling and Instructions for Use (IFU): Prepare labeling and IFU in both Arabic and English, adhering to SFDA requirements.

3. Submit Application

   • Complete Application Form: Fill out the SFDA’s medical device registration application form.
   • Upload Documents: Submit the completed application form and all required documentation through the SFDA’s GHAD (Generic Health and Drug) portal. Ensure all documents are in the required format and meet SFDA specifications.

4. Payment of Fees

   • Fee Submission: Pay the applicable registration fees as outlined by the SFDA. Ensure you keep a record of the payment for your records.

5. SFDA Review Process

   • Initial Review: The SFDA will review the application and may request additional information or clarification. Be prepared to respond promptly to any queries or requests from the SFDA.
   • Technical Evaluation: The SFDA will conduct a technical evaluation of the submitted documentation to ensure compliance with regulatory requirements.

6. Approval and Certification

   • Receive Certificate: Upon successful review and evaluation, the SFDA will issue a registration certificate for the Class C medical device. This certificate allows you to market the device in Saudi Arabia.
   • Compliance: Ensure ongoing compliance with SFDA regulations and requirements.

7. Post-Market Surveillance

   • Monitoring and Reporting: Implement a post-market surveillance plan to monitor device performance and safety. Report any adverse events or issues to the SFDA as required.

8. Renewal and Amendments

   • Renewal: Track the expiration date of your registration and prepare for renewal applications as needed.
   • Amendments: If there are changes to the device or its intended use, submit an amendment to the SFDA for approval.

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