For Class A medical device registration with the Saudi Food and Drug Authority (SFDA), compliance with several standards and guidelines is required to ensure the device meets safety and performance expectations. Here are the key standards and guidelines:

1. International Standards

1.1. ISO 13485:2016

• Quality Management System: This standard outlines requirements for a quality management system that consistently provides medical devices that meet regulatory requirements. While not always mandatory for Class A devices, it is highly recommended.

1.2. ISO 14971:2019

• Risk Management: This standard specifies a process for managing risks associated with medical devices. It involves identifying, evaluating, and controlling risks throughout the device’s lifecycle.

1.3. ISO 10993 Series

• Biocompatibility: These standards provide guidelines for evaluating the biocompatibility of medical devices that come into direct or indirect contact with the human body.

2. SFDA Specific Guidelines

2.1. SFDA Medical Device Regulations

• General Requirements: Adhere to the SFDA’s regulations which cover safety, performance, and labeling of medical devices. Ensure compliance with all regulatory requirements outlined by the SFDA.

2.2. SFDA Guidelines for Medical Device Registration

• Documentation and Submission: Follow the 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. IEC Standards

• Electromagnetic Compatibility (EMC): For electronic medical devices, compliance with IEC standards related to EMC (e.g., IEC 60601-1-2) may be required.
• Safety Standards: For devices involving electrical components, compliance with IEC safety standards (e.g., IEC 60601-1) is necessary.

3.2. National Standards

• Local Adaptations: Be aware of any specific national standards or guidelines that may apply in Saudi Arabia, including any additional local requirements.

4. Labeling Standards

4.1. SFDA Labeling Requirements

• Content: Ensure that product labels include all necessary information such as the device name, manufacturer details, intended use, and any warnings or precautions. Labels may also need to be in Arabic.

5. Clinical and Performance Standards

5.1. Clinical Data Requirements

• Evidence: For some Class A devices, particularly those with more complex features, clinical evidence or performance testing may be required to demonstrate safety and efficacy.

5.2. Performance Testing

• Standards: Follow relevant performance standards for your device’s functionality and intended use to ensure compliance.

6. Good Manufacturing Practices (GMP)

6.1. GMP Compliance

• Manufacturing Practices: Adhere to good manufacturing practices to ensure consistent quality and safety of the device.

7. Compliance with Other Regulations

7.1. Regional and International Regulations

• Conformity: Ensure that the device conforms to any regional or international regulations that may be relevant in addition to SFDA requirements.

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