Yes, B-class medical device registration with the Saudi Food and Drug Authority (SFDA) does require annual reviews for renewal. While the initial registration allows a device to be marketed and sold in Saudi Arabia, the registration is valid for one year only.

Key Points Regarding Annual Review and Renewal:

1. Annual Renewal Requirement:

   • After the initial registration, the manufacturer or its Local Authorized Representative (LAR) must submit a renewal application every year to maintain the validity of the registration.
   • This ensures that the device continues to meet SFDA's safety, quality, and performance standards.

2. Review of Updated Information:

   • During the annual renewal process, SFDA may require updates to the original registration information, such as:
     • Device labeling.
     • Risk management data (if there are changes or new risks identified).
     • Post-market surveillance data, including any adverse event reports or changes in clinical performance.
     • Quality management system updates (e.g., changes to ISO 13485 certification or the manufacturing process).

3. Documentation Submission:

   • Manufacturers or their representatives must submit the necessary documentation for the renewal, which may include:
     • Certificate of compliance with relevant standards.
     • Updated clinical data (if there are any changes or new information).
     • Quality management system certification (if renewed or updated).
     • Post-market surveillance reports (if there have been any safety concerns or corrective actions).

4. Failure to Renew:

   • If the registration is not renewed within the required timeframe, the device will be removed from the market, and the manufacturer may face legal and regulatory consequences, including fines or importation bans.

5. Post-Market Surveillance:

   • As part of the annual review process, manufacturers must report any post-market surveillance data that indicates changes in the device’s safety or performance. This includes adverse events, recalls, or safety issues that may arise from the device's use in the market.

6. Inspection and Audits:

   • In some cases, SFDA may perform inspections or audits of manufacturing facilities as part of the renewal process, especially for higher-risk products or manufacturers that are based outside Saudi Arabia.

Summary of the Annual Review Process:

• Renewal of B-class medical device registration is required annually.
• Manufacturers must submit updated documentation, including clinical data, quality management system certifications, and post-market surveillance reports.
• SFDA will review this information to ensure continued compliance with regulatory standards.
• Failure to submit for renewal may result in the device being removed from the Saudi market.

This annual review process is a key part of ensuring that medical devices continue to meet the safety, efficacy, and quality standards required for their use in Saudi Arabia.