For Class C medical device registration with the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, the technical file must meet specific requirements to ensure that the device complies with SFDA regulations. The technical file should be comprehensive and well-organized, including the following key elements:

Technical File Requirements for Class C Medical Device SFDA Registration

1. Device Description

   • Device Name and Classification: The name of the device and its classification according to SFDA guidelines.
   • Intended Use: Detailed description of the device's intended use, target population, and clinical indications.
   • Device Specifications: Technical specifications, including design and functional features.

2. Manufacturing Information

   • Manufacturing Process: Description of the manufacturing process, including materials, components, and assembly.
   • Quality Control: Information on quality control measures and procedures used during manufacturing.
   • Site Information: Details about the manufacturing site and its facilities.

3. Risk Management

   • Risk Management File: Documentation of risk analysis and risk management processes, as per ISO 14971. This should include identified risks, risk control measures, and the effectiveness of those measures.

4. Clinical Evaluation

   • Clinical Data: Data demonstrating the safety and performance of the device. This may include clinical studies, literature reviews, or other evidence supporting the device's clinical efficacy.
   • Clinical Evaluation Report: A summary of the clinical evaluation, including how the data supports the intended use of the device.

5. Testing Reports

   • Safety and Performance Testing: Results from testing conducted to ensure the device meets safety and performance requirements. This may include:
     • Biocompatibility Testing: If applicable, to demonstrate that the device materials are safe for patient contact.
     • Electrical Safety Testing: For devices with electrical components, showing compliance with relevant safety standards.
     • Other Relevant Testing: Depending on the device type, additional testing reports may be required.

6. Labeling and Instructions for Use (IFU)

   • Labeling: Design and content of the device labels, including any warnings, precautions, and usage instructions. Labels must be in Arabic and English.
   • Instructions for Use (IFU): Detailed instructions on how to use the device, including preparation, operation, and maintenance. The IFU must also be in both Arabic and English.

7. Declaration of Conformity

   • Manufacturer’s Declaration: A statement from the manufacturer declaring that the device conforms to applicable regulatory requirements and standards.

8. Post-Market Surveillance Plan

   • Surveillance Plan: A plan outlining how the device’s performance and safety will be monitored after it is on the market. This includes procedures for collecting and addressing adverse event reports.

9. Regulatory Approvals (if applicable)

   • Evidence of Approvals: If the device has been approved in other jurisdictions (e.g., CE Marking, FDA clearance), include copies of these approvals or certificates.

Additional Notes

• Document Format: Ensure that all documents are in a format that can be easily reviewed and assessed by the SFDA. This may include electronic submissions or specific file formats as required by the SFDA.
• Organization: The technical file should be well-organized and indexed to facilitate the review process.

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