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.

Key Steps for Registering a Class D Medical Device with the SFDA:

1. Determine Device Classification: Ensure that your device is correctly classified as Class D. This classification impacts the level of regulatory scrutiny required.

2. Preparation:

   • Technical Documentation: Gather comprehensive documentation, including device specifications, design and manufacturing details, clinical data, and risk management information.
   • Standards Compliance: Ensure compliance with relevant international standards (e.g., ISO standards).

3. Local Representation: If you are not based in Saudi Arabia, appoint a local authorized representative or agent who will handle communication with the SFDA on your behalf.

4. Register on SFDA System:

   • Create an account on the SFDA’s electronic registration system (SFDAsystem).

5. Prepare and Submit Application:

   • Application Form: Complete the SFDA’s application form for Class D medical devices.
   • Documentation: Upload all required documents, including the device’s technical file, clinical data, and proof of compliance with international standards.
   • Submit Application: Submit your completed application through the SFDA electronic submission system.

6. Fee Payment:

   • Pay the registration fees as specified by the SFDA. Fees may vary depending on the device and the application process.

7. Review Process:

   • The SFDA will review your application. They may request additional information or clarification during this phase.

8. Inspection and Evaluation:

   • For Class D devices, the SFDA may conduct an inspection of the manufacturing site or evaluate the device in more detail.

9. Approval and Certification:

   • Once the SFDA is satisfied with the submitted documentation and evaluation, they will issue a registration certificate.

10. Post-Market Requirements:

    • After registration, comply with post-market surveillance requirements, including reporting any adverse events or device performance issues.

Tips:

• Consult SFDA Guidelines: Refer to the SFDA’s specific guidelines for Class D devices to ensure all requirements are met.
• Regulatory Affairs Expert: Consider consulting with a regulatory affairs expert to navigate the complex registration process efficiently.