Device Description: Detailed description of the device, including its intended use, design, components, and specifications.

Device Classification: Verify that the device is correctly classified as Class D. Class D devices are high-risk and require extensive documentation and scrutiny.

SFDA Portal: The registration process is handled through the SFDA's electronic registration system known as the SFDA Electronic Submission System (SFDAsystem).

Registration Fees: The SFDA charges fees for the registration of medical devices. These fees can vary depending on the type and class of the device. For Class D devices, which are high-risk, the fees are typically higher compared to lower-class devices.

Verification: Ensure that your device is correctly classified as Class D. This classification reflects that it is a high-risk device requiring rigorous scrutiny.

Confirm Classification: Ensure your device is classified as Class D. This is crucial as Class D devices are subject to the highest regulatory scrutiny.

Class D medical devices are classified as high-risk devices by the Saudi Food and Drug Authority (SFDA). They require the most stringent regulatory controls due to their potential impact on patient health and safety. Examples of Class D devices might include certain types of implants, life-supporting devices, or devices used in critical care.

Pre-Submission Preparation: Ensure that your device complies with SFDA regulations. Gather all necessary documentation, including technical files, clinical data, and proof of compliance with international standards.