Preparation Time: Gathering and preparing the required documentation, including technical files, clinical data, and risk management, can take 1 to 3 months depending on the complexity of the device and the availability of data.

Non-Saudi manufacturers must have a Saudi-based Authorized Representative (AR) who is licensed by the SFDA. The AR will handle the registration process and ensure compliance with SFDA regulations.

Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR) who holds a valid SFDA Medical Device Establishment License (MDEL).

Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR) who holds an SFDA Medical Device Establishment License (MDEL).

Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR), who is licensed by the SFDA. This AR will handle the submission process on your behalf.

The SFDA charges fees for processing the registration of a medical device. For Class C devices, the fees typically range between $4,000 to $6,000 USD.

To register a Class C medical device with the Saudi Food and Drug Authority (SFDA), manufacturers must meet specific requirements that ensure the device is safe, effective, and compliant with Saudi Arabian regulations. Class C devices are considered moderate-to-high risk, and their registration requires detailed documentation and evidence of conformity with international standards.

Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR).