For SFDA registration of Class B medical devices in Saudi Arabia, the relevant standards are generally based on international guidelines and SFDA-specific regulations. Here's a detailed overview:

1. International Standards:

1. ISO 13485:2016 - Medical Devices Quality Management Systems:

   • This standard specifies requirements for a quality management system (QMS) that demonstrates an organization’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

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

   • This standard provides a framework for identifying hazards, assessing risks, and controlling these risks throughout the lifecycle of a medical device.

3. ISO 10993 - Biological Evaluation of Medical Devices:

   • This series of standards provides guidelines for the biological evaluation of medical devices to ensure their safety and biocompatibility.

4. IEC 60601 Series - Electrical Safety:

   • These standards cover the safety and essential performance of medical electrical equipment. Relevant parts may include IEC 60601-1 (general requirements), IEC 60601-1-2 (electromagnetic compatibility), and others depending on the device.

5. IEC 62304:2006 - Software Life Cycle Processes:

   • If the medical device incorporates software, this standard outlines the requirements for the development and maintenance of medical device software.

2. SFDA-Specific Regulations:

1. SFDA Technical Regulations:
   • SFDA Guidelines for Medical Devices: These guidelines include requirements for registration, labeling, and post-market surveillance specific to the Saudi Arabian market.
   • SFDA Registration Requirements: Detailed requirements for the documentation and evidence needed to support device registration.

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2. SFDA-Specific Regulations:

1. SFDA Technical Regulations:

   • SFDA Guidelines for Medical Devices: Includes comprehensive requirements for device registration, labeling, and post-market surveillance specific to the Saudi Arabian market. These guidelines align with international standards but may have specific local requirements.
   • SFDA Registration Requirements: Detailed documentation and evidence required for device registration, including safety and effectiveness data, risk management reports, and quality management system certification.

2. Specific SFDA Standards:

   • Saudi Arabian Standards Organization (SASO) Standards: Adhere to SASO standards relevant to medical devices, which may include harmonized standards and local adaptations.
   • Saudi Food and Drug Authority (SFDA) Rules and Procedures: Follow SFDA’s rules and procedures for medical device registration, including specific regulatory pathways, documentation requirements, and fees.

3. Harmonization with International Requirements:

• GHTF/IMDRF Guidelines: SFDA often aligns with guidelines from the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF), which aim to harmonize medical device regulations across different countries.

4. Key Considerations:

• Compliance with Local Requirements: Ensure that your device meets all local regulations and standards in addition to international ones.
• Documentation: Prepare thorough and accurate documentation that demonstrates compliance with both SFDA requirements and international standards.