After applying for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), you must follow various regulations and requirements to ensure ongoing compliance. These include post-approval obligations, monitoring, and documentation updates that are essential for maintaining the registration and marketing the device in Saudi Arabia.

Key Regulations and Requirements to Follow After Applying for D-Class Medical Device Registration:

1. Post-Market Surveillance (PMS)

• Ongoing Monitoring: Even for low-risk (D-class) devices, post-market surveillance is a critical requirement. You need to monitor the device’s performance in the market to ensure its continued safety and effectiveness.

  • Adverse Event Reporting: Report any adverse events, defects, or safety issues that arise during the device’s use to the SFDA within the required time frame (usually within 10 days for serious incidents).
  • Customer Complaints: Record and investigate any complaints regarding the device. Depending on the severity, you may need to provide follow-up information to the SFDA.

• Periodic Reports: Some devices may require periodic post-market surveillance reports or annual updates to the SFDA regarding the device’s safety, effectiveness, and any potential issues.

  • Annual Reports: If requested, submit an annual post-market update to the SFDA detailing any device modifications, adverse events, and feedback from healthcare providers or users.

2. Labeling and Packaging Compliance

• Ensure that the device labeling and packaging continue to comply with SFDA regulations, including the requirement to have Arabic and English labeling.

  • Labeling: The label must provide clear and accurate information such as:
    • The device's name, manufacturer, and country of origin.
    • Intended use, warnings, and precautions.
    • Storage and handling instructions.
    • Expiry date (if applicable).
  • User Manual (IFU): The Instructions for Use (IFU) must also be in both Arabic and English. It should provide clear guidance on how to use, maintain, and dispose of the device safely.

• Any Changes in Labeling: If there are any changes to the labeling or packaging after approval (e.g., updated instructions or new warnings), you must notify the SFDA.

3. Adherence to Quality Management System (QMS)

• You must maintain compliance with Good Manufacturing Practices (GMP) and ensure the Quality Management System (QMS) remains in place and meets the necessary regulatory standards (e.g., ISO 13485).

• Audits: Be prepared for possible SFDA inspections or audits of your manufacturing facility or the Local Authorized Representative (LAR) if there is suspicion of non-compliance.

• Continuous Improvement: If there are changes to the manufacturing process, materials, or components, the QMS should be updated, and the changes must be documented and, where necessary, submitted to the SFDA for approval.

4. Product Modifications or Device Changes

• If there are any changes in the design, composition, intended use, manufacturing site, or performance specifications of the device, you are required to:
  • Notify the SFDA immediately.
  • Submit revised documentation to reflect the changes (e.g., updated risk management files, testing reports, and clinical data if applicable).
  • Re-register or modify the registration if the changes are significant enough to affect the risk classification or performance of the device.

5. Annual Registration Renewal

• Renewal Process: D-class medical device registrations must be renewed annually to maintain their market authorization. The renewal process typically includes:

  • Payment of Annual Fees: These fees are determined by the SFDA and may vary based on the type of device and its classification.
  • Submission of Updated Documentation: Depending on SFDA requirements, you may need to submit updated documents, including post-market surveillance reports, quality system certifications (e.g., ISO 13485), and device safety data.

• Timeliness: It is important to track the registration expiry date and start the renewal process well in advance to avoid any disruption in market access.

6. Reporting Changes in Device Information

• You must inform the SFDA about any significant changes to the device. This could include:
  • Changes in manufacturing processes.
  • Modifications in design or material that may impact the device’s safety or performance.
  • New clinical data or testing results.
  • Changes in distribution or marketing channels in Saudi Arabia.
• Depending on the nature of the change, the SFDA may require you to submit an updated application for device modification or re-registration.

7. Distribution Compliance

• Ensure that your distributors and sales agents in Saudi Arabia are compliant with SFDA regulations.
  • All devices must be distributed through SFDA-registered distributors who adhere to proper storage, transportation, and handling guidelines to ensure product integrity and safety.
• Tracking and Traceability: Be prepared to provide the traceability of devices distributed in Saudi Arabia, especially in the case of recalls or safety issues. This includes maintaining records of batch numbers, lot numbers, and distribution dates.

8. Regulatory Inspections and Audits

• After approval, the SFDA has the right to conduct random inspections of your manufacturing facility or review your technical documentation to ensure ongoing compliance.
  • Self-Audits: Conduct your own internal audits to ensure adherence to SFDA regulations and that any new changes to the device are documented and compliant.
  • Facility Audits: Be prepared for audits or inspections of the manufacturing facility, especially if there are updates to the product or its manufacturing process.

9. Complaint Handling and Device Recall Procedures

• You must have a complaint handling system in place to capture, investigate, and resolve any issues raised by users or healthcare providers about the device.
  • Complaint Investigation: Investigate any complaints related to the safety, performance, or quality of the device and report significant findings to the SFDA.
• Device Recall: If a device is found to be unsafe or defective, it may need to be recalled from the market. You must have a recall plan in place to handle this, including:
  • Notifying the SFDA and affected stakeholders.
  • Issuing public safety notifications if necessary.
  • Ensuring that the affected devices are safely returned or disposed of.

10. Stay Informed of SFDA Regulatory Updates

• Regulatory Changes: SFDA regulations may evolve over time, and you must stay updated on any new or amended regulations that could affect your device registration or marketing practices.
  • Subscribe to SFDA updates or work with regulatory consultants to ensure ongoing compliance.
• New Requirements: Be aware of any changes in classification rules, technical documentation requirements, or post-market obligations that might affect your device or its renewal.

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