To apply for Class D medical device registration with the Saudi Food and Drug Authority (SFDA), several conditions must be met. These conditions ensure that the device complies with regulatory standards and is safe and effective for use. Here are the key conditions:

1. Device Classification

• Confirm Classification: Ensure that the device is correctly classified as Class D. Class D devices are considered high-risk and require extensive documentation and review.

2. Documentation Requirements

• Technical File: Prepare a comprehensive technical file that includes:

  • Device description
  • Design and manufacturing information
  • Performance characteristics
  • Clinical data supporting safety and effectiveness
  • Risk management report

• Compliance with International Standards:

  • Proof of compliance with relevant international standards, such as ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management for Medical Devices).
  • Include certificates or declarations of conformity.

• Labeling and Instructions:

  • Ensure that the product labeling complies with SFDA requirements, including details like device name, manufacturer, intended use, and any warnings or contraindications.
  • Provide clear and comprehensive instructions for use.

3. Clinical Data

• Clinical Evaluation: Provide clinical data or evaluation reports demonstrating that the device is safe and effective for its intended use. This might include clinical trials, studies, or literature reviews.

4. Risk Management

• Risk Analysis: Include a detailed risk management file outlining identified risks, risk assessment, and mitigation strategies, in accordance with ISO 14971.

5. Quality Management System

• QMS Implementation: Ensure that your manufacturing facility has a Quality Management System (QMS) in place that complies with SFDA and international standards (e.g., ISO 13485).

6. Local Representation

• Authorized Representative: If your company is not based in Saudi Arabia, you must appoint a local authorized representative or agent who will handle communications with the SFDA.

7. Compliance with SFDA Guidelines

• Regulatory Guidelines: Adhere to the SFDA’s specific guidelines and regulations for Class D medical devices. This includes ensuring all submitted documents and processes meet SFDA standards.

8. Application Fees

• Fee Payment: Be prepared to pay the applicable registration fees. Ensure you understand the fee structure and make timely payments through the SFDA’s payment system.

9. Ethical Approvals

• Ethical Review: If your device has been involved in clinical trials or studies, provide documentation of ethical approvals and informed consent.

10. Translation Requirements

• Document Translation: Translate any necessary documents into Arabic if required by the SFDA. Ensure translations are accurate and professional.

11. Device and Manufacturer Information

• Device Details: Provide detailed information about the device, including specifications, intended use, and any applicable standards.
• Manufacturer Information: Include information about the manufacturer, including their address, contact details, and evidence of good manufacturing practices.

Key Considerations

• Accuracy and Completeness: Ensure that all information and documents are accurate, complete, and up-to-date to avoid delays or rejections.
• Timeliness: Submit your application and documents promptly to adhere to the SFDA’s timelines and avoid unnecessary delays.
• Consultation: Consider consulting with a regulatory affairs expert or legal advisor to navigate the application process effectively.

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