After obtaining SFDA registration for Class B medical devices, you must adhere to several ongoing regulations and requirements to ensure continued compliance and regulatory approval:

1. Post-Market Surveillance:

• Monitor Device Performance: Continuously monitor the device's performance and safety in the market. Collect and analyze data on device use and effectiveness.
• Report Adverse Events: Report any adverse events or incidents involving the device to SFDA promptly. This includes any malfunctions, side effects, or safety issues.

2. Compliance with SFDA Regulations:

• Adhere to SFDA Guidelines: Follow all SFDA guidelines related to medical device operation, maintenance, and updates. Ensure that the device continues to meet regulatory requirements.
• Document Updates: If there are significant changes to the device, manufacturing processes, or labeling, document these changes and notify SFDA as required.

3. Quality Management System (QMS):

• Maintain ISO 13485 Certification: Keep your QMS certification up to date and ensure that your quality management practices remain compliant with ISO 13485 or equivalent standards.
• Conduct Internal Audits: Regularly perform internal audits of your QMS to identify and address any issues.

4. Labeling and Packaging:

• Ensure Accurate Labeling: Maintain compliance with SFDA labeling requirements, including language (Arabic and English) and content accuracy. Ensure that any updates to the labeling are promptly updated and compliant.
• Update Packaging: If there are changes in packaging or labeling, ensure these changes comply with SFDA regulations.

5. Renewals and Amendments:

• Registration Renewal: Be aware of the renewal schedule for your registration. Submit renewal applications and necessary documents in a timely manner.
• Amendments: Submit any amendments to the registration, such as changes in device specifications or manufacturer details, to SFDA for approval.

6. Post-Market Obligations:

• Conduct Post-Market Studies: If required, conduct post-market clinical follow-up studies or evaluations to ensure the continued safety and effectiveness of the device.
• Implement Corrective Actions: Address any issues identified through post-market surveillance or inspections with appropriate corrective and preventive actions.

7. Documentation and Reporting:

• Maintain Records: Keep detailed records of all compliance activities, including adverse event reports, corrective actions, and communication with SFDA.
• Periodic Reports: Submit any required periodic reports to SFDA, such as safety updates or performance reviews.

8. Training and Support:

• Provide Training: Ensure that your staff and customers are trained on the safe and effective use of the device. Provide ongoing support and updates as needed.

9. Compliance with Local Regulations:

• Adhere to Local Standards: Stay informed about any changes in local regulations and standards that may affect your device and ensure compliance with updated requirements.