For Class C medical device registration in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires compliance with a range of international and local standards to ensure safety, performance, and quality. These standards form the backbone of the technical documentation, risk management, clinical evaluation, and quality systems you must submit.

🏷️ Key Standards Applicable to Class C Medical Device Registration in Saudi Arabia

1. ISO 13485 — Medical Devices Quality Management System

• Specifies requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices.

• Mandatory for manufacturers to obtain ISO 13485 certification from an accredited body before applying for registration.

• SFDA uses this as a baseline to assess manufacturer’s quality controls.

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

• Specifies a systematic process for identifying hazards, estimating and evaluating risks, controlling risks, and monitoring the effectiveness of controls.

• A complete risk management file following ISO 14971 must be submitted as part of the technical documentation.

3. IEC 60601 Series — Medical Electrical Equipment Safety and Performance

• Applies to electrical medical devices, including safety, essential performance, and electromagnetic compatibility.

• Important for devices like infusion pumps, electrosurgical units, and diagnostic imaging equipment common in Class C.

4. IEC 62304 — Medical Device Software — Software Life Cycle Processes

• Required if the device includes software or is software as a medical device (SaMD).

• Specifies software development, maintenance, risk management, and validation processes.

5. ISO 15223-1 — Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied

• Defines symbols and labeling requirements to standardize communication on device packaging and IFU.

• Arabic translations must comply with labeling standards.

6. ISO 10993 Series — Biological Evaluation of Medical Devices

• Relevant if the device involves direct or indirect contact with patients.

• Includes biocompatibility testing to assess risks like toxicity, irritation, or sensitization.

7. SFDA Essential Principles of Safety and Performance

• SFDA requires demonstration of compliance with its Essential Principles, adapted from GHTF and IMDRF frameworks.

• These cover design, manufacture, clinical performance, labeling, and post-market surveillance.

8. Other Applicable International Standards

• IEC 61010 (Safety requirements for electrical equipment for measurement, control, and laboratory use)

• ISO 14155 (Good Clinical Practice for clinical investigations)

• GMP (Good Manufacturing Practice) in line with ISO 13485 or SFDA-specific requirements

• UDI (Unique Device Identification) requirements per SFDA guidelines

📌 Summary Table

Additional Notes

• SFDA generally accepts CE, FDA, TGA, or other internationally recognized certifications that demonstrate compliance with these standards.

• Arabic labeling and IFU requirements must meet SFDA’s local regulatory framework.

• Always check SFDA’s latest guidelines or notifications for updates or additions to applicable standards.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn