Yes, an annual review is required for MDACS (Medical Device Administrative Control System) registration of Class III in vitro diagnostic (IVD) medical devices in Hong Kong. Here are the key aspects regarding the annual review process:

1. Purpose of the Annual Review

• The annual review is designed to ensure that the registered devices continue to meet the regulatory standards for safety, efficacy, and quality over time. This process helps maintain compliance with the MDACS requirements and allows for ongoing monitoring of the device's performance in the market.

2. Key Components of the Annual Review

• Post-Market Surveillance Data: Manufacturers must collect and analyze post-market surveillance data, including any adverse events or incidents reported regarding the device.
• Quality Management System (QMS) Updates: Manufacturers should assess and update their QMS, ensuring that it reflects any changes in manufacturing processes, device design, or regulatory requirements.
• Risk Management Review: A review of the risk management file should be conducted to evaluate any new risks that may have emerged during the device's lifecycle.
• Clinical Performance Data: Manufacturers should review and report any new clinical performance data that may affect the safety or efficacy of the device.

3. Documentation Requirements

• Manufacturers are required to prepare documentation that reflects the findings of the annual review. This documentation should summarize:
  • Any changes made to the device or its manufacturing processes.
  • Results of the post-market surveillance, including any adverse events.
  • Updates to the QMS and risk management files.

4. Submission to MDCO

• The results of the annual review, along with any necessary documentation, should be submitted to the Medical Device Control Office (MDCO) as part of the compliance requirements. This submission helps demonstrate the manufacturer's commitment to maintaining device safety and performance.

5. Implications of Non-Compliance

• Failure to conduct and submit the annual review can result in non-compliance with MDACS requirements, which may lead to penalties, suspension of registration, or other regulatory actions.

Conclusion

The annual review is a crucial component of the MDACS registration process for Class III IVD medical devices. It ensures that manufacturers continually assess and improve their devices and systems, contributing to ongoing patient safety and regulatory compliance. Regular reviews also help manufacturers respond proactively to any emerging safety issues or changes in the clinical landscape, ultimately fostering trust among healthcare providers and patients.