The process for SFDA (Saudi Food and Drug Authority) registration of Class B medical devices involves several key steps. Here’s a comprehensive overview of the process:

1. Pre-Application Preparations

1. Device Classification:

   • Confirm that the device is accurately classified as Class B according to SFDA guidelines.

2. Quality Management System (QMS):

   • Ensure that the manufacturer has an ISO 13485 certification or equivalent QMS in place.

3. Technical Documentation:

   • Prepare all required technical documentation, including device description, design and manufacturing information, clinical evidence, risk management documentation, and labeling.

4. Authorized Representative (if applicable):

   • For non-Saudi manufacturers, appoint a local authorized representative in Saudi Arabia.

2. Registration Application

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 application system.

2. Complete Application Form:

   • Fill out the online registration application form. Provide accurate and comprehensive information about the device, including its classification, intended use, and technical details.

3. Submit Required Documents:

   • Upload all necessary documents to the SFDA e-Services portal. This typically includes:
     • Device description and specifications
     • ISO 13485 certification
     • Risk management and clinical evidence
     • Labeling and packaging information
     • Quality management system details
     • Authorized representative details (if applicable)

4. Pay Registration Fees:

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

3. SFDA Review Process

1. Initial Review:

   • SFDA will conduct an initial review of the submitted application and documents. This may include checking for completeness and compliance with submission requirements.

2. Technical Review:

   • A technical review of the device's documentation and evidence is performed to ensure it meets SFDA standards. This may involve evaluating clinical data, risk management, and device safety and effectiveness.

3. Request for Additional Information:

   • SFDA may request additional information or clarification during the review process. Respond promptly and accurately to any such requests.

4. Inspection (if required):

   • SFDA may conduct an inspection of the manufacturing facility or audit the quality management system if deemed necessary.

4. Registration Decision

1. Approval Notification:

   • If the application is approved, SFDA will issue a registration certificate. This certificate confirms that the device is authorized for marketing and distribution in Saudi Arabia.

2. Registration Number:

   • Obtain and record the SFDA registration number for your device. This number should be included on the device labeling.

5. Post-Registration Requirements

1. Post-Market Surveillance:

   • Implement post-market surveillance to monitor the device’s performance and safety. Report any adverse events or issues to SFDA as required.

2. Renewal and Updates:

   • Be aware of the registration renewal process and timelines. Submit any updates or amendments to SFDA as necessary, such as changes in device specifications, labeling, or manufacturing processes.

3. Ongoing Compliance:

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

6. Ongoing Communication

1. Stay Informed:

   • Keep abreast of any changes in SFDA regulations and guidelines that may affect your device.

2. Respond to Inquiries:

   • Be prepared to respond to any inquiries or requests from SFDA regarding your device.

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