To obtain SFDA registration for Class B medical devices, follow these detailed steps:

1. Pre-Application Preparation

1. Device Classification:

   • Confirm that your device is classified as Class B according to SFDA guidelines. This ensures that the registration process and requirements are correctly identified.

2. Quality Management System (QMS):

   • Ensure your manufacturing facility is certified to ISO 13485 or an equivalent QMS standard. This certification is crucial for regulatory compliance.

3. Technical Documentation:

   • Gather all necessary technical documentation, including:
     • Device description and intended use
     • Design and manufacturing information
     • Risk management documentation
     • Clinical evidence or performance data
     • Labeling and packaging information

4. Authorized Representative:

   • If the manufacturer is not based in Saudi Arabia, appoint a local authorized representative who will act as a liaison with SFDA.

2. Application Process

1. Create an SFDA e-Services Account:

   • Register on the SFDA e-Services portal (https://www.sfda.gov.sa/en/e-services) to access the online application system.

2. Complete the Application Form:

   • Log in to the SFDA e-Services portal and fill out the online registration application form. Provide comprehensive information about the device, including classification, intended use, and technical details.

3. Prepare and Submit Required Documents:

   • Upload all necessary documents to the SFDA e-Services portal, including:
     • Device specifications and technical details
     • ISO 13485 certification
     • Risk management and clinical data
     • Labeling and packaging information
     • Details of the authorized representative (if applicable)
   • Ensure all documents are complete and formatted as required by SFDA guidelines.

4. Pay Registration Fees:

   • Pay the applicable registration fees through the SFDA e-Services portal. Fees vary depending on the device and registration type.

3. Review and Approval Process

1. Initial Review:

   • SFDA will perform an initial review to check if the application is complete and meets submission requirements. This usually takes 1-2 weeks.

2. Technical Review:

   • SFDA will conduct a detailed technical review of the device’s documentation, including clinical evidence, risk management, and safety data. This stage typically takes 1-3 months, depending on the complexity of the device.

3. Inspection (if required):

   • If necessary, SFDA may schedule an inspection of the manufacturing facility or audit the quality management system. This can add several weeks to the process.

4. Approval Notification:

   • Upon successful completion of the review, SFDA will issue a registration certificate. This confirms that the device is approved for marketing and distribution in Saudi Arabia.

4. Post-Registration Requirements

1. Post-Market Surveillance:

   • Implement a system for monitoring the device’s performance and safety in the market. Report any adverse events or issues to SFDA as required.

2. Renewal and Updates:

   • Be aware of the registration renewal process and submit any necessary updates or amendments to SFDA. This includes changes in device specifications, labeling, or manufacturing processes.

3. Compliance:

   • Ensure ongoing compliance with SFDA regulations and guidelines, including maintaining an effective quality management system and adhering to labeling requirements.