Yes, Class D medical device registration with the Saudi Food and Drug Authority (SFDA) generally requires periodic renewal, although the specific renewal frequency may not necessarily be annual. Here’s how the renewal process typically works:

1. Registration Validity

• Validity Period: The registration of a Class D medical device with the SFDA is typically valid for a certain number of years. For many medical devices, this period is usually 5 years, but the exact duration can vary based on SFDA regulations and the type of device.

2. Renewal Process

• Renewal Application: Before the registration expires, manufacturers must apply for renewal to continue marketing and distributing the device in Saudi Arabia.
• Documentation: The renewal application may require updated documentation, including current technical files, clinical data, risk management information, and post-market surveillance reports.
• Fees: Renewal usually involves paying a renewal fee, which is outlined by the SFDA’s fee structure.

3. Key Considerations

• Timely Renewal: It is important to initiate the renewal process well before the registration expires to avoid any interruptions in the device’s market availability.
• Compliance Updates: During the renewal process, manufacturers should ensure that their device continues to comply with any updated SFDA regulations or standards that may have changed since the initial registration.

4. Monitoring Regulatory Changes

• Stay Informed: Manufacturers should keep up-to-date with any changes in SFDA regulations or guidelines that could impact the renewal process or the requirements for maintaining registration.

5. Post-Renewal

• Ongoing Requirements: After successful renewal, manufacturers must continue to meet all SFDA regulatory requirements, including post-market surveillance and compliance with any new standards or guidelines.