After applying for D-class medical device SFDA registration in Saudi Arabia, the manufacturer or authorized representative must continue to adhere to a range of regulatory requirements to maintain compliance with SFDA regulations. D-class devices are considered high-risk, and SFDA has stringent oversight to ensure that these devices are safe, effective, and properly monitored throughout their lifecycle.

Here’s a summary of the key regulations and requirements that must be followed after applying for D-class medical device SFDA registration:

1. Post-Market Surveillance (PMS) and Vigilance

• Monitoring Device Performance: As a high-risk device, it is essential to establish an ongoing Post-Market Surveillance (PMS) system to monitor the performance and safety of the device once it is on the market.
• Adverse Event Reporting: Any adverse events (e.g., device malfunctions, injuries, or death) must be reported to the SFDA within a defined period, typically within 15 days for serious incidents. Adverse event reporting is critical for high-risk devices to ensure timely corrective actions are taken if necessary.
• Periodic Safety Update Reports (PSUR): For D-class devices, you may be required to submit Periodic Safety Update Reports to SFDA. These reports provide ongoing data on the safety and effectiveness of the device in real-world use.
• Field Safety Corrective Actions (FSCA): If a safety issue arises, you may need to initiate corrective actions such as recalls, device modifications, or safety notifications. These actions must be communicated to SFDA.

2. Quality Management System (QMS) Compliance

• Maintain ISO 13485 Certification: You must maintain ISO 13485:2016 certification to ensure your quality management system (QMS) is in compliance with SFDA requirements. This includes maintaining strict controls over manufacturing, design, testing, and distribution.
• Regular Audits: Conduct regular internal audits and management reviews to ensure continuous compliance with SFDA regulations and international standards.
• Document Control and Traceability: Keep a record of all documentation related to the device, including design, testing, risk management, and any post-market feedback. This documentation must be traceable and accessible to SFDA if needed.

3. Labeling and Instructions for Use (IFU)

• Labeling Compliance: Ensure that your device labeling complies with SFDA regulations. Labels must include:
  • The name of the device, the manufacturer, and the intended use.
  • Warnings, contraindications, and precautions.
  • Lot number, expiry date (if applicable), and batch information.
  • Arabic translation of the required information.
• Instructions for Use (IFU): Provide clear and detailed IFUs that include:
  • The device’s intended use, operation instructions, contraindications, and any risks associated with the device.
  • These must also be translated into Arabic.
  • If there are any changes to the device’s intended use or its labeling, the SFDA must be notified, and the updated documentation must be resubmitted for approval.

4. Annual Registration Renewal

• Annual Registration Renewal: The registration for D-class medical devices is typically valid for one year. To maintain your device’s approval, you must submit a renewal application annually before the expiration date. This process includes submitting updated safety reports, performance data, and other relevant information.
• Updating Clinical Data: If new clinical data becomes available, it must be submitted to the SFDA as part of the renewal process.
• Ongoing Compliance: Ensure that all relevant documents, including the Post-Market Surveillance Plan, are updated and submitted for renewal.

5. Notifying SFDA of Changes

• Changes to Device Specifications: Notify the SFDA if there are any significant changes to the device, such as modifications in design, intended use, or labeling. You must also report changes in the manufacturing process or the supplier of critical materials/components.
• Changes to Manufacturing Location: If there are any changes in the manufacturing site or the manufacturing process that could affect device quality or safety, SFDA must be notified. This may require an updated application or submission of new documentation.
• Software Updates: If the device includes software, any updates or modifications to the software that could affect its safety or performance must be reported to the SFDA.

6. Distribution and Importation

• Authorized Distributor Requirements: If your device is being distributed in Saudi Arabia, the local distributor must be registered with the SFDA and have the proper importation licenses. The importer must adhere to SFDA requirements for storage, transportation, and distribution of the device.
• Importation Documentation: The importer must maintain proper records of the importation process and ensure that the device complies with SFDA regulations upon arrival in Saudi Arabia.

7. Adverse Event Reporting and Corrective Actions

• Adverse Event Reporting: In the event of any adverse reactions or device failures, manufacturers or their authorized representatives must report incidents to the SFDA within the required timeframes. This is a critical aspect of regulatory compliance, especially for high-risk D-class devices.
• Corrective and Preventive Actions (CAPA): You are required to establish and maintain a CAPA system to address any issues identified during post-market surveillance or in response to adverse events. Corrective actions could include device recalls, software patches, labeling changes, or process modifications.

8. Inspection and Audits

• SFDA Inspections: SFDA may conduct inspections of the manufacturing facility or the authorized representative to ensure ongoing compliance with regulations. Be prepared for periodic audits to verify adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.
• Third-Party Audits: If applicable, ensure that any third-party organizations involved in manufacturing, testing, or certification are also compliant with SFDA requirements.

9. Global Compliance and Regulatory Reporting

• International Approvals: If your D-class medical device is marketed in other countries (e.g., EU, US), ensure that you are compliant with international regulations, and that any changes made to the device in Saudi Arabia are consistent with the requirements of other regulatory bodies.
• Reporting to Other Authorities: If the device is sold in other markets, provide updates to other regulatory bodies (e.g., FDA, European Medicines Agency (EMA)) regarding any adverse events or changes made to the device in Saudi Arabia.

10. Corrective Actions and Device Recall

• Device Recall: If a safety issue arises, you may need to initiate a recall. The SFDA requires timely communication of any corrective actions, such as recalls, and proper documentation of the process.
• Root Cause Analysis: After a recall, perform a root cause analysis to determine the underlying issue. Implement corrective actions and preventive measures to avoid similar problems in the future.

11. Regulatory Fees and Updates

• Fees: Ensure that any applicable SFDA fees for post-market activities, such as registration renewal, adverse event reporting, or audit fees, are paid promptly. These fees are subject to change, so stay updated on any changes in the fee structure.
• Regulatory Changes: Stay informed about updates to SFDA regulations. Medical device regulations may evolve over time, and you must be prepared to adjust your processes and documentation to stay in compliance.

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