For SFDA registration of Class B medical devices, the technical documentation requirements are quite detailed. Here’s a comprehensive list of the documents you’ll need to prepare:

Technical Documentation Requirements:

1. Device Description:

   • Detailed Description: Include information on the device’s intended use, functionality, and design.
   • Principle of Operation: Explain how the device works, including its operational mechanisms and intended therapeutic or diagnostic benefits.

2. Design and Manufacturing Information:

   • Design Documentation: Provide detailed drawings, schematics, and specifications of the device.
   • Manufacturing Process: Describe the manufacturing processes, including quality control measures, and any changes made to the device design.
   • Component and Material Specifications: Information about the materials used in the device and their specifications.

3. Quality Management System (QMS):

   • ISO 13485 Certification: Submit a copy of the ISO 13485 certification or equivalent quality management system certification.
   • QMS Documentation: Provide details on how the QMS is implemented and maintained in the manufacturing process.

4. Clinical Evidence:

   • Clinical Data: Include clinical trials, performance evaluations, or literature reviews demonstrating the safety and effectiveness of the device.
   • Clinical Study Reports: If applicable, provide reports from any clinical studies conducted on the device.

5. Risk Management:

   • Risk Management File: Document the risk management process, including risk assessments, identified risks, and mitigation measures.
   • Risk Analysis and Evaluation: Provide details on how risks associated with the device are evaluated and managed.

6. Instructions for Use:

   • User Manuals: Detailed instructions for safe and effective use of the device.
   • Labeling: Include information on labeling requirements, such as warnings, precautions, and instructions. Ensure compliance with SFDA regulations on language (Arabic and English) and symbol use.

7. Packaging Information:

   • Packaging Details: Information on packaging materials and design, including how the device is protected during transport and storage.
   • Sterilization: If applicable, include details on the sterilization process and validation.

8. Manufacturing and Quality Records:

   • Production Records: Provide records related to the production of the device, including batch records and quality control tests.
   • Change Control: Documentation of any changes made to the device design or manufacturing process and their impact on device safety and performance.

9. Legal and Regulatory Documentation:

   • Business Registration: Proof of the manufacturer’s legal status and registration.
   • Authorized Representative: If the manufacturer is outside Saudi Arabia, include details of the authorized representative in Saudi Arabia.
   • Certificate of Free Sale: If available, a certificate showing that the device is marketed in other countries.

10. Additional Documents:

    • Certificate of Compliance: Proof of compliance with relevant international standards, if applicable.
    • Testing Reports: Include reports from any testing conducted on the device, such as electrical safety tests or biocompatibility tests.

Preparation Tips:

• Ensure Accuracy and Completeness: Verify that all documents are complete and accurately reflect the device’s characteristics and compliance with regulatory requirements.
• Consult SFDA Guidelines: Review the SFDA guidelines and requirements to ensure that all necessary documentation is included.
• Professional Translation: If required, ensure that documents are accurately translated into Arabic.