Periodic updates of MDACS registration for Class III in vitro diagnostic (IVD) medical devices in Hong Kong are essential for ensuring ongoing compliance with regulatory standards and addressing any changes that may occur in the product lifecycle. Here are the key standards and processes involved in the periodic update of MDACS registration:

Standards for Periodic Updates

1. ISO 13485:2016

   • Ongoing compliance with ISO 13485 is crucial for maintaining a quality management system. This standard mandates continuous improvement and regular reviews of the QMS to adapt to changes, including product updates and regulatory requirements.

2. ISO 14971:2019

   • This standard for risk management emphasizes the need for regular risk assessments, particularly when there are changes to the device or its use. Updates to the risk management file should reflect any new risks identified through post-market surveillance.

3. Regulatory Compliance Standards

   • Adherence to any additional local regulations or guidelines provided by the Medical Device Control Office (MDCO) is necessary, including updates or changes to existing regulations that may affect device registration.

4. Clinical Standards

   • If there are changes in clinical evidence, manufacturers should comply with relevant clinical guidelines and standards, ensuring that updated clinical data reflects any modifications to the device's intended use or indications.

Processes for Periodic Updates

1. Monitoring Changes

   • Identify Changes: Regularly assess the device and its performance data, manufacturing processes, or regulatory landscape for any changes that may necessitate an update.
   • Document Changes: Keep detailed records of any changes, including rationale, impact assessments, and necessary supporting documentation.

2. Conducting Reviews

   • Quality Management System Review: Regularly review the QMS to identify areas for improvement and to ensure that it remains compliant with ISO 13485 and other applicable standards.
   • Risk Management Review: Update the risk management file to include new risks identified through post-market surveillance or changes in the device.

3. Updating Technical Documentation

   • Revise Technical File: If there are significant changes to the device, update the technical documentation accordingly. This includes revising device descriptions, labeling, clinical data, and manufacturing information.

4. Notifying Regulatory Authorities

   • Submit Updates: Depending on the nature of the updates, submit revised documentation and information to the MDCO, especially for significant changes that may affect safety or effectiveness.
   • Communicate Changes: Inform the MDCO of any major changes that require their attention or may affect the registration status of the device.

5. Re-evaluation and Recertification

   • Determine Need for Re-evaluation: Assess whether the changes require re-evaluation of the device under MDACS guidelines, which may involve additional clinical trials or data submissions.
   • Recertification Process: If required, initiate the recertification process to ensure continued compliance with regulatory standards.

6. Maintaining Communication with Stakeholders

   • Engage with Users and Healthcare Providers: Gather feedback from users to assess the impact of any changes on device performance and usability.
   • Collaborate with Regulatory Experts: Maintain communication with regulatory affairs specialists to stay updated on any changes in requirements or best practices.

7. Post-Market Surveillance Updates

   • Review PMS Data: Continually analyze post-market surveillance data to ensure that the device performs as intended and that any adverse events are promptly addressed.
   • Update PMS Plans: Revise the post-market surveillance plan as necessary based on the latest data and device modifications.

Conclusion

Periodic updates to MDACS registration for Class III IVD medical devices require a systematic approach to monitoring, reviewing, and documenting changes in compliance with established standards. By following these processes and adhering to the relevant standards, manufacturers can ensure that their devices remain compliant and safe for continued use in the market. Regular updates also help maintain the trust of stakeholders, including healthcare providers and patients, while supporting the device's long-term success.

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