Class C medical device SFDA registration in Saudi Arabia generally does not require annual inspections specifically for the registration process itself. However, there are several ongoing requirements and obligations that manufacturers must fulfill to maintain compliance and ensure the safety and effectiveness of their medical devices:

Ongoing Obligations and Requirements

1. Post-Market Surveillance:

   • Monitoring: Manufacturers must implement a post-market surveillance system to monitor the performance of the device once it is on the market. This involves tracking adverse events, complaints, and any other issues related to the device.
   • Reporting: Adverse events and device performance issues must be reported to the SFDA as required. This helps in ensuring continuous safety monitoring.

2. Quality Management System (QMS) Maintenance:

   • Compliance: Manufacturers must maintain their Quality Management System (QMS) in compliance with standards such as ISO 13485. This involves regular internal audits and updates to the QMS as necessary.
   • Continuous Improvement: The QMS should be regularly reviewed and improved based on findings from post-market surveillance and other feedback.

3. Renewal of Registration:

   • Registration Renewal: The registration for Class C medical devices needs to be renewed periodically. The specific renewal period can vary, so it is important to check SFDA requirements for the exact renewal timeline.

4. Documentation Updates:

   • Labeling and IFU: Any updates or changes to the device, its labeling, or instructions for use (IFU) must be communicated to the SFDA. This ensures that all information provided to users remains accurate and up-to-date.

5. Compliance with SFDA Requirements:

   • Regulatory Changes: Stay updated on any changes to SFDA regulations or guidelines that may affect the device. Manufacturers are responsible for ensuring ongoing compliance with all applicable regulations.

6. Audits and Inspections:

   • Manufacturing Site Inspections: While there may not be a specific annual inspection requirement for registration, SFDA or other regulatory bodies may conduct inspections of manufacturing sites or facilities to ensure compliance with regulatory standards. These inspections can occur as part of routine oversight or in response to specific issues.