Yes, D-class medical device SFDA registration in Saudi Arabia requires annual renewal.

The SFDA issues a registration certificate for your medical device, and this certificate is typically valid for one year. To maintain your device’s market access in Saudi Arabia, you need to renew the registration annually. Here's what you need to know about the renewal process:

Key Points about Annual Renewal for D-Class Medical Device SFDA Registration

1. Timeline for Renewal:

   • The renewal process typically starts within 90 days before the expiration date of your registration.
   • It’s recommended to start the renewal process early to avoid any disruptions in the availability of your device in the market.

2. Required Documents:

   • In most cases, you will need to submit updated documents for the renewal, which may include:
     • Proof of continued compliance with SFDA regulations.
     • Post-market surveillance data or updates, including adverse event reports (if applicable).
     • Any changes to labeling or device information.
     • Updated GMP certification (for manufacturing sites, if applicable).

3. Review Process:

   • SFDA will typically review your renewal application to ensure that your device remains compliant with current safety and performance standards.
   • If no significant changes have occurred, the renewal process is usually straightforward and may not require extensive documentation.

4. Regulatory Fees:

   • Renewal often involves the payment of renewal fees, which may vary depending on the type and classification of the device.

5. Failure to Renew:

   • If you fail to renew the registration in a timely manner, your device may be removed from the market and you may be required to go through the entire registration process again.
   • This could result in delays in distributing or selling the device in Saudi Arabia.

6. Inspection or Additional Requirements:

   • In some cases, SFDA may request additional inspections or updated clinical data to ensure that the device continues to meet required standards. This is particularly important for high-risk D-class devices that require regular post-market surveillance.

Summary

While D-class medical devices in Saudi Arabia must be initially registered with SFDA, the registration is typically valid for one year. After that, annual renewal is required to keep the device on the market. Ensuring timely renewal and maintaining up-to-date documentation is critical for continued market access in Saudi Arabia.

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