Handling the SFDA (Saudi Food and Drug Authority) registration for a Class C medical device in Saudi Arabia involves several key steps. Class C devices are considered moderate-to-high-risk, so the process is more rigorous compared to lower-class devices. Here is an overview of the steps:

1. Appoint a Saudi Authorized Representative (AR)

• Non-Saudi manufacturers must appoint an Authorized Representative (AR) based in Saudi Arabia. The AR will liaise with the SFDA and is responsible for the device’s registration and post-market surveillance.

2. Create a Saudi-Dedicated Establishment

• The AR must be registered as a local establishment with the SFDA. They will create an account in the SFDA Medical Device Establishment Licensing (MDEL) system.

3. Pre-Submission Preparations

• Ensure that the medical device has been approved or registered in reference countries such as the EU (CE Mark), USA (FDA), or other trusted markets.
• Collect and organize the necessary documentation, which typically includes:
  • Technical file or dossier (device description, design, risk management)
  • Clinical evidence and safety data
  • Declaration of Conformity
  • Quality Management System (ISO 13485 certification)
  • Device labeling and instructions for use (in both English and Arabic)
  • Device classification and relevant safety tests or certifications

4. SFDA Medical Device Marketing Authorization (MDMA) Application

• Submit the marketing authorization application through the GHAD system (SFDA’s e-services portal) under the Medical Device Marketing Authorization (MDMA) section.
• Ensure that all documents comply with SFDA’s guidelines, and the dossier is in line with the requirements for a Class C device.

5. Technical Review

• The SFDA will conduct a technical review of the submitted documents, evaluating safety, performance, clinical evidence, and labeling. Class C devices are subject to a detailed review due to their higher risk profile.

6. Post-Market Surveillance and Vigilance

• Once the device is approved, the manufacturer and AR must comply with post-market surveillance requirements, including adverse event reporting, periodic safety updates, and post-market clinical follow-up (if required).

7. SFDA Approval

• After completing the review, SFDA will grant the marketing authorization for the device, allowing it to be legally sold in Saudi Arabia. The certificate typically lasts for 3 to 5 years.

8. Post-Approval Obligations

• Regularly update the SFDA on any changes to the device or its intended use.
• Continue to monitor the device’s safety and effectiveness in the Saudi market.

Key Considerations:

• Timeline: The approval process may take 6-12 months, depending on the device complexity and SFDA’s review pace.
• Fees: There are application fees associated with the SFDA registration, which can vary based on the device class and complexity.

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