No, Class C medical device registration with the Saudi Food and Drug Authority (SFDA) does not require an annual review. However, there are key post-market obligations and periodic updates that manufacturers must comply with to maintain the device's registration status in Saudi Arabia:

1. Registration Validity and Renewal:

• Registration Validity: Once a Class C medical device is registered, the registration certificate is typically valid for 5 years.
• Renewal: At the end of the 5-year period, manufacturers will need to renew the registration. The renewal process involves updating the documentation, ensuring continued compliance with SFDA requirements, and possibly submitting new data (e.g., post-market surveillance reports, updated labeling, or any new clinical evidence).

2. Post-Market Surveillance and Reporting:

• While there isn't an annual review, manufacturers are required to have a post-market surveillance system in place. This includes:
  • Monitoring the device’s performance once it's in the market.
  • Reporting adverse events or any safety concerns to the SFDA in a timely manner.
  • Periodic safety updates: Manufacturers may need to provide the SFDA with safety reports or updates about the product's performance in the market, especially if there are any changes or issues related to its safety, efficacy, or quality.

3. Periodic Reporting and Updates:

• Change Notifications: If there are significant changes to the device (e.g., modifications in design, intended use, manufacturing process, or labeling), manufacturers must inform the SFDA. These changes may require additional documentation or re-evaluation of the device.
• Manufacturing Site Inspections: The SFDA may also conduct inspections of the manufacturing site or require updates on the Good Manufacturing Practices (GMP) compliance status during the 5-year registration period.

4. Compliance with SFDA Standards and New Regulations:

• Regulatory Updates: Manufacturers must stay updated with any changes in SFDA regulations, standards, or guidelines. The SFDA may introduce new requirements or modify existing ones, and manufacturers must ensure that their device continues to comply with these updated regulations.

5. Annual Audits and Inspections (if applicable):

• Facility Inspections: If your manufacturing facility is located outside of Saudi Arabia, the SFDA may conduct periodic inspections to verify compliance with Good Manufacturing Practices (GMP). This may not be annual but could occur at regular intervals or if the SFDA deems it necessary.
• Quality System Audits: Depending on the complexity of the device, manufacturers may be subject to audits to ensure continued compliance with quality systems and regulatory standards.

Summary:

• No annual review is required for Class C medical device registration with the SFDA.
• The registration is valid for 5 years, after which it needs to be renewed.
• Post-market obligations such as adverse event reporting, periodic safety updates, and ensuring compliance with changing regulations are required.
• Significant changes to the device or its manufacturing process must be reported to the SFDA, and inspections may be carried out periodically, but these are typically not on an annual basis.

To maintain your product’s registration status and ensure compliance, it's important to stay engaged with the SFDA's regulatory updates and continue to monitor the device’s performance in the market.

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