For Class C medical device registration with the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, compliance with various standards is crucial. These standards ensure the device's safety, performance, and quality. Here are the key standards and guidelines you need to adhere to:

Key Standards for Class C Medical Device SFDA Registration

1. International Standards

   • ISO 13485:2016: This is the standard for quality management systems (QMS) specific to medical devices. It outlines requirements for a comprehensive quality management system for the design, manufacturing, and distribution of medical devices.
   • ISO 14971:2019: This standard provides a framework for risk management for medical devices. It includes guidelines for identifying hazards, assessing risks, and implementing controls to manage those risks.
   • IEC 60601 Series: For medical electrical devices, compliance with the IEC 60601 standards is required. This includes:
     • IEC 60601-1: General requirements for basic safety and essential performance.
     • IEC 60601-1-2: Electromagnetic compatibility requirements.
     • IEC 60601-1-6: Usability requirements.
   • ISO 10993 Series: For biocompatibility testing of materials used in medical devices. It includes various parts focusing on different aspects of biocompatibility, such as:
     • ISO 10993-1: Evaluation and testing within a risk management process.
     • ISO 10993-5: Tests for in vitro cytotoxicity.
     • ISO 10993-10: Tests for irritation and delayed-type hypersensitivity.

2. SFDA-Specific Guidelines

   • SFDA Medical Device Regulations: Follow the specific guidelines and regulations outlined by the SFDA for medical device registration. These regulations provide detailed requirements for documentation, testing, and compliance.
   • SFDA Technical Guidance Documents: Review and adhere to the technical guidance documents issued by the SFDA, which provide detailed instructions on specific aspects of the registration process.

3. Labeling Requirements

   • Saudi National Standard (SNS) 1311: This standard provides guidelines for the labeling of medical devices, including required information and format.
   • SFDA Labeling Guidelines: Ensure that the labeling and Instructions for Use (IFU) comply with SFDA requirements, including bilingual labels (Arabic and English).

4. Clinical Evaluation Standards

   • ISO 14155:2020: This standard covers the requirements for clinical investigations of medical devices for human subjects. It outlines procedures for planning, conducting, and reporting clinical investigations.

5. Post-Market Surveillance

   • ISO 13485:2016: Includes requirements for post-market surveillance and reporting of adverse events.

Compliance and Documentation

• Ensure that all standards and guidelines are thoroughly documented in the technical file submitted to the SFDA.
• Provide evidence of compliance with these standards through testing reports, certifications, and quality management system documentation.

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