To apply for D-class medical device SFDA registration with the Saudi Food and Drug Authority (SFDA), several important conditions must be met. These conditions relate to both the device itself and the manufacturer or authorized representative. Below are the key conditions that must be fulfilled to ensure a successful application:

1. Classification of the Device

The device must be classified as D-class under SFDA’s medical device classification system. D-class devices are considered high-risk, which means they are critical to patient health and safety. They typically include:

• Implantable devices.
• Life-supporting or life-sustaining devices.
• Devices that pose significant potential risks to patients, operators, or public health.

To apply for registration as a D-class device, you must ensure that your device:

• Meets SFDA’s high-risk classification criteria.
• Aligns with international standards for high-risk medical devices (e.g., MDR, FDA, ISO 13485, ISO 14971).

2. Compliance with SFDA Medical Device Regulations

The device must comply with all relevant SFDA medical device regulations, including:

• SFDA's Medical Device Interim Regulations.
• The Gulf Cooperation Council (GCC) medical device guidelines, if applicable.
• ISO standards, such as ISO 13485 (Quality Management System), and ISO 14971 (Risk Management for Medical Devices).

For D-class devices, these regulations are more stringent due to the high-risk nature of the device.

3. Manufacturer and Authorized Representative Requirements

• Manufacturing Facility Requirements: The manufacturer must follow Good Manufacturing Practices (GMP) to ensure product quality and consistency. The facility must be capable of meeting SFDA’s requirements for medical device production, and the ISO 13485 certification is often a requirement for high-risk devices.
• Local Authorized Representative (for Foreign Manufacturers): If the manufacturer is located outside of Saudi Arabia, they must appoint a local authorized representative in Saudi Arabia. The authorized representative is responsible for liaising with the SFDA and submitting all required documentation on behalf of the manufacturer.
  • The local representative must be registered with SFDA and authorized to handle the device's regulatory affairs in Saudi Arabia.

4. Clinical and Risk Management Documentation

• Clinical Evidence: Clinical data must be provided to demonstrate the device’s safety and efficacy. For D-class devices, the clinical evaluation is particularly important, and the SFDA may require comprehensive clinical trial data or post-market surveillance data from other markets (e.g., CE, FDA).
  • Clinical data should include clinical studies, preclinical testing, and any post-market performance data.
  • Clinical Evaluation Report (CER): The CER should summarize all available clinical evidence, including literature reviews, clinical trials, and post-market data, especially for life-supporting and implantable devices.
• Risk Management: A comprehensive Risk Management File based on ISO 14971 is required, including:
  • Risk analysis and assessment.
  • Risk control measures.
  • Residual risk after mitigation measures have been applied.

5. Conformity with International Standards

• The device should conform to applicable international standards. This is particularly important for D-class devices due to their higher risk. Examples include:
  • ISO 13485 for the quality management system.
  • ISO 14971 for risk management.
  • IEC 60601 for electrical safety (if applicable).
  • ISO 10993 for biocompatibility (for devices in contact with the human body).
  • CE Marking or FDA Approval: If the device has been approved in the European Union (with CE marking) or the United States (with FDA clearance or approval), the SFDA may accept these approvals as part of the application process.

6. Labeling and Packaging Compliance

• Device Labeling: The device must have appropriate labeling that complies with SFDA’s labeling regulations. Labels should include:
  • Device name and model.
  • Manufacturer’s details.
  • Intended use and instructions for use (IFU).
  • Warnings, contraindications, and precautions.
  • Serial number, batch number, and expiration date (if applicable).
• Packaging: The device packaging should be suitable for its intended use, especially if it is sterile or has specific storage requirements. The packaging must also comply with SFDA’s standards for safety and traceability.

7. Quality Management System (QMS) Compliance

• ISO 13485 Certification: The manufacturer must be certified to ISO 13485 (Medical Devices — Quality Management Systems). This certification ensures that the manufacturer follows a robust quality management system throughout the design, development, and manufacturing processes.
• The SFDA may also require evidence of ongoing compliance with QMS through audits, surveillance, or inspections, especially for high-risk devices.

8. Device Testing Data

• Pre-Clinical and Clinical Testing Data: For D-class medical devices, comprehensive preclinical testing and clinical studies are often required to demonstrate safety and performance. This may include:

  • Biocompatibility testing (e.g., ISO 10993).
  • Electrical safety testing (e.g., IEC 60601).
  • Performance testing (e.g., mechanical, software, or sterilization testing).

• Performance and Safety Data: If the device is already marketed in other regions (e.g., Europe, U.S.), the performance and safety data from those markets may be included as part of the submission to the SFDA.

9. Payment of Registration Fees

• The applicant (either the manufacturer or the local authorized representative) must pay the registration fees to SFDA. The fee amount will depend on the risk classification of the device (D-class devices generally have higher fees) and the complexity of the registration process.

10. Post-Market Surveillance and Compliance

• Once the device is approved, it must comply with post-market surveillance requirements set by SFDA, especially for high-risk devices:
  • Adverse event reporting.
  • Device recalls if necessary.
  • Post-market clinical follow-up (PMCF) to monitor long-term safety and performance.
  • Regular reporting to the SFDA of any issues related to device performance, safety, or adverse effects.

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