For Class D medical device registration with the Saudi Food and Drug Authority (SFDA), the technical documentation requirements are extensive due to the high-risk nature of these devices. Here’s a detailed list of the technical document requirements:

1. Device Description

• General Description: Provide a detailed description of the device, including its intended use, design, components, and specifications.
• Functionality: Explain how the device works, its operating principles, and how it achieves its intended purpose.

2. Design and Manufacturing Information

• Design Details: Include design drawings, diagrams, and specifications that show how the device is constructed and functions.
• Manufacturing Processes: Document the manufacturing processes, including methods, equipment used, and quality control measures.
• Quality Management System (QMS): Evidence of compliance with QMS standards, such as ISO 13485. Include QMS documentation and audit reports if applicable.

3. Clinical Data

• Clinical Evaluation: Provide comprehensive clinical evaluation reports that demonstrate the device’s safety and effectiveness. This includes clinical trials, studies, or literature reviews.
• Clinical Trial Data: If clinical trials were conducted, include trial protocols, results, and ethical approvals.

4. Risk Management

• Risk Management File: Include a detailed risk management file that outlines identified risks, risk assessments, and risk mitigation strategies. This should be in accordance with ISO 14971.
• Risk Analysis and Evaluation: Document the methods used for risk analysis and the results of risk evaluations.

5. Performance Testing

• Test Reports: Include reports from performance testing that demonstrate the device meets its intended performance specifications.
• Biocompatibility Testing: For devices that come into contact with the body, provide evidence of biocompatibility testing.

6. Labeling and Instructions for Use

• Product Labeling: Provide samples or drafts of the product labeling, including device name, manufacturer details, intended use, and any warnings or contraindications.
• Instructions for Use (IFU): Detailed and clear instructions for the safe and effective use of the device. Ensure that these instructions are comprehensive and understandable.

7. Compliance with International Standards

• Certificates of Compliance: Include certificates or declarations of conformity with relevant international standards such as ISO 13485 and ISO 14971.
• Standards Documentation: Provide documentation showing compliance with specific standards relevant to the device.

8. Manufacturing Site Information

• Facility Details: Provide information about the manufacturing facility, including address, contact information, and evidence of compliance with good manufacturing practices (GMP).
• Inspection Reports: Include any relevant inspection reports or certifications for the manufacturing site.

9. Labeling and Packaging

• Labeling Requirements: Ensure that all labeling meets SFDA requirements. This includes labels on the device and packaging that provide necessary information and warnings.
• Packaging Specifications: Provide details about packaging materials and methods used to ensure the device’s protection during storage and transport.

10. Post-Market Surveillance

• Post-Market Data: Outline any post-market surveillance plans or data collection methods for monitoring the device’s performance after it’s on the market.
• Adverse Event Reporting: Describe the system in place for reporting and managing adverse events related to the device.

11. Ethical Approvals

• Ethical Review Documents: If clinical trials or studies were conducted, provide documentation of ethical approvals and informed consent processes.

Preparation Tips

• Organize Clearly: Ensure that all documents are well-organized and clearly labeled to facilitate the review process.
• Ensure Accuracy: Double-check all information for accuracy and completeness to avoid delays.
• Consult Guidelines: Review the SFDA’s specific guidelines for Class D medical devices to ensure that all required information is included.

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