For Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), manufacturers must comply with several standards and follow established procedures to ensure that the device remains in compliance with regulatory requirements and is kept up-to-date with any changes. Regular updates are essential to maintain the validity of the registration, especially in light of new regulatory changes, safety data, and product modifications.

Standards and Procedures for Regular Updates:

1. Annual Registration Renewal

• Renewal Process: The registration for a Class I IVD medical device is generally valid for 5 years. To maintain the device's registration, manufacturers must submit a renewal application before the expiration date.
  • Application Form: The renewal application form must be completed and submitted to the Hong Kong Department of Health.
  • Documentation: Manufacturers may need to provide updated documentation, such as changes to the device, updated labeling, performance data, or a reaffirmation of the device’s compliance with regulatory standards.
  • Fee Payment: The manufacturer must also pay the relevant renewal fees, which are set by the Hong Kong Department of Health.

2. Update on Device Information

Manufacturers are required to notify the Hong Kong Department of Health of any significant changes to the registered information about the device, including:

• Changes in Intended Use: If there are any changes in the indications or intended use of the IVD device (e.g., a new test indication or a change in the clinical application).
• Design Changes: Significant modifications to the device design, materials, or components, which may affect its safety or performance.
• New or Updated Performance Data: Any new clinical trial results, lab data, or performance evaluation studies that impact the safety, effectiveness, or accuracy of the device.
• Labeling Changes: Any updates to the labeling or instructions for use (IFU) that affect the user instructions, warnings, or safety information.

3. Post-Market Surveillance and Data Reporting

• Adverse Event Reporting: Manufacturers must regularly update the authorities about any adverse events related to the IVD device. This includes any serious incidents or malfunctions that could compromise patient safety.
  • Reports of adverse events must be submitted within 15 days of the manufacturer becoming aware of the event.
  • Corrective Actions: Manufacturers are also required to update the authorities on any corrective or preventive actions (CAPA) taken in response to reported incidents.
• Post-Market Clinical Follow-Up: Manufacturers must monitor and update the safety and performance of the device. If any new risks or benefits are identified, or if there are significant changes in the clinical data, this should be reported to the Hong Kong authorities.

4. Updating Quality Management System (QMS) and Risk Management Documentation

• QMS Compliance: Manufacturers should keep their Quality Management System (QMS) up to date with any relevant changes, such as modifications to processes, standards, or manufacturing practices. This includes updating documents related to the design, manufacturing, and quality control processes.
  • Manufacturers should ensure compliance with ISO 13485 and other relevant international standards.
• Risk Management Updates: Any new risk assessments or changes in the device’s risk profile due to updated data, adverse events, or device modifications should be documented.
  • ISO 14971 (Risk management for medical devices) should be used to update the risk analysis.

5. Notification of Significant Device Changes

• If there are modifications to the manufacturing process, the device's components, or packaging, the manufacturer must notify the Hong Kong Department of Health.
• For substantial changes, the device might require a re-assessment, which could involve resubmitting documentation, such as performance test data or new risk assessments.

6. Updating Importer and Distributor Information

• Manufacturers must inform the Hong Kong Department of Health of any changes to their authorized representative, importer, or distributor.
  • If a new distributor is appointed, their details should be provided.
  • The manufacturer or authorized representative must ensure that all parties involved in the distribution of the device are compliant with the local regulations.

7. Monitoring Compliance with International Standards

• Regular Review of Standards: Manufacturers should stay informed about any updates to international standards that may affect the IVD device. This could include changes to standards such as:
  • ISO 13485 (Quality Management Systems for medical devices).
  • ISO 14971 (Risk management).
  • ISO 18113 (Labeling of IVD devices).
• If there are updates to these standards, the manufacturer must ensure the device is compliant and update their documentation or practices accordingly.

8. Advertising and Promotional Materials Updates

• If there are changes to the advertising or promotional materials for the device, the manufacturer must ensure that all claims made are consistent with the approved indications and performance data.
  • Marketing materials should not make unsubstantiated claims or misrepresent the device’s capabilities.

9. Inspections and Audits

• The Hong Kong Department of Health may conduct inspections or audits to ensure that the device continues to meet regulatory requirements. Manufacturers should be prepared for these inspections and ensure that all records, including updated documentation, are accessible.
  • Ensure that the device and all relevant documentation are compliant with Hong Kong's medical device regulations.

10. Document Retention

• Manufacturers must maintain documentation related to the device, including:
  • Design, manufacturing, and testing records.
  • Quality management system documentation.
  • Post-market surveillance records.
• These records must be retained for a minimum of 5 years after the device has been discontinued or removed from the market.

Conclusion

Regular updates for Class I IVD medical device registration under Hong Kong MDACS involve several key processes, including annual registration renewal, reporting changes to the device or its performance, and maintaining post-market surveillance activities. Manufacturers are required to keep all documentation current, comply with international standards, and notify the Hong Kong authorities of significant device changes, adverse events, or any updates to labeling or quality systems. Staying proactive and compliant with these updates ensures continued market access and regulatory compliance.

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