For Class D medical device registration in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) expects compliance with internationally recognized technical and safety standards that demonstrate the device’s safety, performance, and quality. These standards largely align with global benchmarks such as those set by the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and others.

Key Standards Applicable to Class D Medical Devices in Saudi Arabia

1. ISO 13485:2016 — Medical Devices Quality Management System

• Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services.

• Mandatory certification recognized by SFDA for manufacturers.

2. ISO 14971:2019 — Application of Risk Management to Medical Devices

• Framework for identifying hazards, estimating and evaluating risks, controlling risks, and monitoring the effectiveness of controls.

• Essential for Class D devices due to high risk.

3. IEC 60601 Series — Medical Electrical Equipment Safety

• Covers general safety and essential performance requirements for medical electrical equipment.

• Often includes collateral and particular standards for specific device types.

• Applies to electronic, software-controlled devices in Class D.

4. ISO 10993 Series — Biological Evaluation of Medical Devices

• Standards for assessing the biocompatibility of materials that come into contact with the body.

• Critical for implants and invasive devices.

5. ISO 62304 — Medical Device Software Lifecycle Processes

• Applies to software as a medical device (SaMD) or software integral to medical devices.

• Specifies processes for software development and maintenance.

6. ISO 11607 — Packaging for Terminally Sterilized Medical Devices

• Requirements for materials, sterile barrier systems, and packaging processes.

• Important for sterile Class D devices.

7. ISO 11135 / ISO 11137 — Sterilization Validation

• Standards for sterilization of medical devices using ethylene oxide (11135) or radiation sterilization (11137).

• Sterilization process validation is critical for implants and invasive devices.

8. ISO 15223-1 — Symbols for Medical Device Labeling

• Standardizes symbols used on medical device labels and instructions for use.

• SFDA requires labels and IFU to be bilingual (Arabic and English) with proper symbol usage.

9. ISO 20417 — Information to be Supplied by Manufacturer

• Specifies the information that manufacturers must provide to users, typically in the IFU.

10. Other Device-Specific Standards

• Depending on device type, additional IEC/ISO standards may apply. For example:

  • ISO 17511 for metrological traceability of IVD devices.

  • ISO 14155 for clinical investigations of medical devices.

  • Relevant standards for orthopedic implants, cardiovascular devices, etc.

Additional Notes

• SFDA may accept CE marking under EU MDR, FDA clearance, or other internationally recognized approvals that rely on these standards.

• Compliance with these standards must be demonstrated in your technical documentation and Declaration of Conformity (DoC).

• SFDA may audit compliance during registration or post-market surveillance.

Summary Table

If you want, I can help you identify the specific standards applicable to your exact device model or assist in preparing the Declaration of Conformity referencing these standards for SFDA submission.

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