Yes, D-class medical device registration with the Saudi Food and Drug Authority (SFDA) does require periodic updates and annual review to maintain compliance. While the specifics can vary based on the device and its classification, here are the key points to consider regarding the ongoing review and renewal requirements for D-class devices:

1. Annual Review or Update Requirement:

• Annual Maintenance: For D-class medical devices, the SFDA requires that registered devices undergo an annual maintenance review to ensure that the information about the device remains accurate and up-to-date.
• This includes ensuring that any changes in the device's manufacturing process, technical specifications, labeling, or quality management system (e.g., ISO 13485) are reported and verified.

2. Documentation and Submission:

• Annual Update of Information: You may be required to submit updated documents related to the device’s performance, safety data, or manufacturing information.
  • For instance, if there are updates to your device’s labeling, packaging, or marketing materials, these changes need to be submitted for review.
  • If there are any modifications to the device or its intended use, the SFDA may require a re-evaluation to ensure continued compliance.
• Post-Market Surveillance Reports: Devices, even low-risk D-class ones, are subject to post-market surveillance, and the manufacturer must report any adverse events or complaints related to the device. Failure to submit these reports annually can lead to regulatory action.

3. Continuous Compliance:

• Quality Management System (QMS) Audits: If your device is ISO 13485 certified, you need to maintain the certification, which often requires annual audits. This certification is essential to demonstrate the device's consistent quality and compliance.

• Periodic Inspections or Audits: In some cases, the SFDA may conduct audits or inspections to verify compliance with Saudi regulations. Although less common for D-class devices (due to their lower-risk profile), audits can still happen based on specific circumstances.

4. Device Renewal:

• Registration Renewal: While the specific renewal process for D-class devices may not be as rigorous as for higher-risk devices (such as Class C or D), renewal of registration may still be required after a certain period (typically every 5 years).
  • This renewal process may involve submitting updated documents and verifying that the device is still compliant with current regulations and standards.

5. SFDA Monitoring:

• The SFDA may periodically update its guidelines, regulations, and standards for medical devices. Manufacturers are responsible for staying updated on any regulatory changes and ensuring that their device continues to comply with new or revised regulations.

Summary of Ongoing Requirements for D-Class Medical Device Registration:

• Annual Maintenance Review: Update your device information annually to ensure continued compliance.
• Post-Market Surveillance: Report any adverse events or changes in device performance as required.
• Quality Management System Maintenance: Keep your ISO 13485 certification current and ensure annual audits are conducted.
• Device Renewal: Periodic re-registration (typically every 5 years) may be required, which includes verifying ongoing compliance.

Conclusion:

While the D-class medical device registration with the SFDA doesn't require extensive annual reviews like higher-risk devices, there are still annual updates and periodic reviews to maintain the device’s registered status. Compliance with ongoing regulatory changes, quality management requirements, and post-market surveillance are essential for ensuring continued market access in Saudi Arabia.

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