For D-class medical device SFDA registration in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) follows a set of stringent regulatory requirements and standards. These standards ensure that high-risk medical devices (D-class) are safe, effective, and of high quality before they are allowed to be marketed and sold in Saudi Arabia.

Key Standards for D-Class Medical Device SFDA Registration

1. SFDA Medical Device Interim Regulations

The primary regulatory framework for medical devices in Saudi Arabia is the SFDA Medical Device Interim Regulations, which align with international guidelines and standards. The SFDA regulations cover various aspects of medical device registration, including:

• Classification of medical devices based on risk (A, B, C, D).
• Quality management and manufacturing practices.
• Clinical evaluation requirements for high-risk devices.
• Post-market surveillance and adverse event reporting.

For D-class devices (high-risk devices), these regulations are particularly strict due to their potential to cause harm to patients or users if they fail to function correctly.

2. ISO 13485:2016 – Medical Devices Quality Management Systems

• ISO 13485 is one of the key standards that D-class medical devices must comply with to ensure that they meet the quality management system (QMS) requirements for design, development, production, and post-market monitoring.
• This standard focuses on processes and controls for manufacturing high-quality, reliable devices, ensuring that the manufacturer follows robust practices for risk management, documentation, and traceability.
• A valid ISO 13485 certification from an accredited body is often required as part of the SFDA registration process for D-class devices.

3. ISO 14971:2019 – Risk Management for Medical Devices

• ISO 14971 outlines the risk management process for medical devices, which is crucial for D-class medical devices. High-risk devices must have a risk management file that includes:
  • Risk analysis to identify potential hazards.
  • Risk evaluation to assess the severity and probability of identified risks.
  • Risk control measures to mitigate those risks to an acceptable level.
  • Residual risk analysis after control measures are applied.
  • Continuous monitoring of risks throughout the lifecycle of the device.
• Compliance with ISO 14971 ensures that manufacturers have a systematic approach to identifying and managing risks associated with their devices, which is critical for D-class devices due to their potential harm.

4. ISO 10993 – Biological Evaluation of Medical Devices

• If the D-class medical device has direct or indirect contact with the human body (e.g., implantable devices, devices in contact with mucosal membranes), it must meet ISO 10993 standards for biological evaluation.
• The device must undergo biocompatibility testing to ensure that it does not pose a risk of toxicity, infection, or allergic reactions when used.
• The ISO 10993 series includes various tests, such as:
  • Cytotoxicity testing.
  • Sensitization and irritation tests.
  • Hemocompatibility (if blood contact is involved).
  • Genotoxicity and carcinogenicity testing.
  • Implantation studies for devices that remain in the body for extended periods.

5. IEC 60601 – Medical Electrical Equipment Standards

For D-class devices that include electrical components (e.g., life-supporting or implantable devices), compliance with IEC 60601 is required. This standard covers the electrical safety, performance, and electromagnetic compatibility (EMC) of medical electrical equipment.

• IEC 60601 ensures that medical electrical equipment is safe for use and does not pose an electrical hazard to patients, users, or third parties.
• The standard also addresses potential electromagnetic interference (EMI) and ensures that devices meet requirements for electromagnetic compatibility (EMC).

6. IEC 62304 – Software Life Cycle Processes (for Software-Based Devices)

• If the D-class medical device includes software (e.g., diagnostic tools, software-controlled devices, or devices with embedded software), the manufacturer must comply with IEC 62304.
• IEC 62304 provides requirements for the software life cycle of medical devices, including:
  • Software design and development.
  • Software verification and validation.
  • Software risk management.
  • Post-market software maintenance.
• This ensures that the software used in medical devices operates correctly, safely, and securely, and minimizes the risks associated with software failure.

7. ISO 14155 – Clinical Investigation of Medical Devices

• ISO 14155 outlines the requirements for clinical investigations involving medical devices. For D-class devices, this is particularly important, as clinical data is often required to demonstrate the device’s safety and performance.
• The clinical investigation process must follow ethical guidelines and ensure that the device has undergone adequate clinical trials or studies to substantiate its intended use and claims.
• Clinical data can include pre-market clinical trials, real-world evidence, or post-market surveillance data from other markets (such as the EU or US), especially if the device has been approved in those regions.

8. ISO 15223-1 – Symbols to Be Used with Medical Device Labels

• For proper device labeling, ISO 15223-1 specifies the symbols that must be used on medical device labels. These symbols help provide key information about the device in a standardized manner and are required for compliance.
• Symbols include: device sterility status, single-use or reusable device, use-by dates, and any other warnings or instructions that need to be communicated clearly to the user.

9. GCC Medical Device Regulations (GSO 1500)

• Saudi Arabia, as a member of the Gulf Cooperation Council (GCC), may also require compliance with the GCC Medical Device Regulations (GSO 1500), which harmonize medical device regulations across GCC countries.
• These regulations are based on international standards and provide additional guidance on registration procedures, device classification, and post-market surveillance requirements within the GCC region.

10. Other Relevant Standards

• ISO 11737 – Sterilization of medical devices: This standard provides methods for sterilizing medical devices, especially relevant for sterile D-class devices.
• ISO 20417 – Labeling of medical devices: Provides requirements for the labeling of medical devices, including information about intended use, warnings, contraindications, and instructions.
• ISO 10993-7 – Part 7: Ethylene oxide sterilization residuals. Relevant for devices sterilized with EO gas.
• ISO 14160 – Ethylene oxide sterilization of health care products, particularly relevant for devices sterilized by ethylene oxide.

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