The technical document requirements for D-class medical device SFDA registration in Saudi Arabia are rigorous due to the high-risk nature of these devices. The Saudi Food and Drug Authority (SFDA) mandates that the applicant submit comprehensive technical documentation to ensure the safety, effectiveness, and compliance of the device with local regulations.

Key Technical Document Requirements for D-Class Medical Device SFDA Registration

1. Application Form

• Complete the SFDA application form for medical device registration. This form requires:
  • Basic device details (name, model, type, and classification).
  • Manufacturer details (name, address, contact information).
  • Local authorized representative (if applicable).
  • Intended use of the device.
  • Risk classification of the device (D-class).

2. Device Description

• A detailed description of the medical device, including:
  • Device function and intended purpose.
  • Components and materials used in the device (e.g., if the device is implantable or life-supporting).
  • Mode of action: How the device works (mechanical, electrical, software, etc.).
  • Classification rationale: Explanation of why the device is classified as D-class, considering its risks and intended use.

3. Clinical Evaluation Report (CER)

• A clinical evaluation report (CER) is essential for D-class devices due to their high-risk status. This document should include:
  • Clinical data: Data demonstrating the safety and performance of the device.
  • Clinical studies: If applicable, summaries of clinical trials, real-world evidence, or literature reviews that support the device's clinical performance.
  • Post-market clinical follow-up (PMCF) data, if the device is already on the market in other regions.
  • Risk-benefit analysis: A comprehensive evaluation of the clinical benefits versus the potential risks.

4. Risk Management File

• A Risk Management File is critical, especially for D-class devices. It should be prepared according to ISO 14971 standards and should include:
  • Risk analysis and assessment.
  • Risk control measures applied to mitigate identified risks.
  • Residual risks after mitigation, with an explanation of how the remaining risks are acceptable.
  • Risk management process throughout the product lifecycle, including design, manufacturing, and post-market surveillance.

5. Conformity Assessment Documentation

• Evidence of conformity with international standards and regulations, including:
  • ISO 13485: A certificate demonstrating compliance with the Quality Management System standard.
  • ISO 14971: Proof of compliance with risk management standards.
  • ISO 10993: If the device comes into contact with the human body, biocompatibility testing data based on ISO 10993 must be provided.
  • Electrical safety testing: For devices that include electrical components, IEC 60601 or similar standards for electrical safety and performance.
  • Sterility testing: If the device is sterile, provide testing reports in accordance with relevant international standards.
  • CE Marking or FDA Approval: If the device has been cleared or approved in other jurisdictions (e.g., CE marking in the EU or FDA approval in the U.S.), provide the relevant documentation, including certificates and reports.

6. Manufacturing and Quality Control Documentation

• Proof of Good Manufacturing Practice (GMP) and quality control compliance, including:
  • ISO 13485 certification: Certification confirming that the manufacturer follows a structured quality management system.
  • Evidence of compliance with GMP standards in the design, production, and testing of the device.
  • Manufacturing site information: Details about the manufacturing site and its ability to meet quality and regulatory standards.
  • Documentation of any supplier controls and the materials used in the device.

7. Labeling and Instructions for Use (IFU)

• Device labeling must comply with SFDA guidelines and should include:
  • Device name, model, and serial number.
  • Manufacturer's name and contact information.
  • Intended use of the device.
  • Warnings, contraindications, and precautions.
  • Instructions for use (IFU): A user manual that provides clear instructions on how to properly use, maintain, and dispose of the device. This must also include safety information, potential side effects, and any contraindications.
  • Shelf life and storage conditions (if applicable).
  • Symbols as per international standards (ISO 15223-1), such as those indicating sterility, temperature range, or use-by date.

8. Performance Testing Data

• Provide performance testing data to demonstrate the device's functionality under normal use conditions. This may include:
  • Preclinical testing: Testing data to show the device performs as intended and meets safety requirements.
  • Mechanical performance (e.g., for implantable devices, wear and tear testing, biomechanical analysis).
  • Software validation: If the device contains software, evidence of validation and testing to ensure it works safely and effectively.
  • Electromagnetic compatibility (EMC) testing: If the device includes electronic components, EMC testing data is required to demonstrate that the device will not cause interference with other devices and that it is immune to interference.

9. Sterility Assurance (if applicable)

• If the device is sterile, you must provide:
  • Sterilization method used (e.g., EO, gamma irradiation, autoclaving).
  • Sterility validation reports: Demonstrating that the sterilization process is effective and consistent.
  • Shelf life data for the sterile device.

10. Post-Market Surveillance Plan

• For high-risk devices like D-class, SFDA may require a post-market surveillance plan to monitor the device's safety and performance once it is on the market. The plan should include:
  • Adverse event reporting: Procedures for reporting any negative incidents or device malfunctions.
  • Periodic safety update reports (PSUR): Regular updates on the device's safety profile post-market.
  • Recalls and corrective actions: A clear process for handling device recalls or corrective actions if safety issues arise after the device is in use.

11. Declaration of Conformity

• A Declaration of Conformity from the manufacturer that the device complies with all relevant SFDA regulations, international standards, and medical device requirements.

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