For Class A medical device registration with the Saudi Food and Drug Authority (SFDA), several standards and guidelines must be adhered to, though specific requirements may vary based on the device and its intended use. Here are the key standards and guidelines to consider:

1. International Standards

1.1. ISO 13485:2016

• Quality Management System: While not always mandatory for Class A devices, ISO 13485 certification is a widely recognized standard for quality management systems in medical device manufacturing. It ensures that manufacturers have effective processes for quality control.

1.2. ISO 14971:2019

• Risk Management: This standard provides guidelines for risk management processes throughout the lifecycle of a medical device. It helps manufacturers identify, assess, and mitigate risks.

1.3. ISO 10993 Series

• Biocompatibility: For devices that come into direct contact with the body, the ISO 10993 series provides standards for evaluating the biocompatibility of medical devices.

2. SFDA Specific Guidelines

2.1. SFDA Medical Device Regulations

• Compliance: Ensure that the device complies with the SFDA’s specific regulations and guidelines for medical devices. These include general requirements for safety, performance, and labeling.

2.2. SFDA Guidelines for Medical Device Registration

• Documentation Requirements: Follow SFDA’s detailed guidelines for the documentation required for Class A medical devices, including technical documentation, labeling, and risk management.

3. Product-Specific Standards

3.1. Relevant IEC Standards

• Electromagnetic Compatibility (EMC): For electronic devices, compliance with IEC standards for EMC (e.g., IEC 60601-1-2) may be necessary.
• Safety Standards: Devices that involve electrical components must meet applicable IEC safety standards (e.g., IEC 60601-1).

3.2. National Standards

• Local Adaptations: In some cases, additional national standards or guidelines specific to Saudi Arabia may apply. Check for any local adaptations or additional requirements.

4. Labeling Standards

4.1. SFDA Labeling Requirements

• Content: Labels must include information such as the device name, manufacturer details, intended use, and any warnings or precautions. Labels should also be in Arabic if required by SFDA guidelines.

5. Clinical and Performance Standards

5.1. Clinical Data Requirements

• Evidence: For devices requiring clinical evidence, adhere to relevant standards for clinical evaluations and performance testing, as applicable.

5.2. Performance Standards

• Testing: Follow performance standards relevant to the device’s functionality and intended use.

6. Compliance with Good Manufacturing Practices (GMP)

6.1. GMP Compliance

• Manufacturing Practices: Adherence to good manufacturing practices ensures that devices are consistently produced and controlled according to quality standards.

7. Additional Considerations

7.1. Documentation and Submissions

• Electronic Submission: Ensure that all documents are formatted according to SFDA requirements for electronic submission via the Unified Electronic Platform (UAE).

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