In Hong Kong, maintaining Class III medical device MDACS registration involves periodic updates to ensure continued compliance with the Medical Device Administrative Control System (MDACS). The process includes updates to the device’s registration, changes to its technical documentation, and submission of necessary reports. Here’s an overview of the standards and procedures for these periodic updates:

1. Regulatory Requirements for Periodic Updates

• Regulation Compliance: Medical devices registered under MDACS must remain compliant with Hong Kong's Medical Device Ordinance (Cap. 622). Any significant changes to the device or its performance, design, composition, labeling, or manufacturing processes require updating the registration with the Hong Kong Department of Health (DoH).

• Annual Reporting: Some Class III medical devices require an annual report to the Department of Health, summarizing post-market surveillance, safety performance, and any corrective actions taken during the year.

2. Procedural Requirements for Periodic Updates

The update process involves ensuring that all relevant documentation is kept current and accurate. The following are typical procedures for periodic updates:

• Update of Registration Information:

  • If there are any changes in the device or its regulatory status, the registered entity (the manufacturer or authorized representative) must submit updated technical documentation to the DoH.

  • Changes could include modifications to the device design, manufacturing process, intended use, or the marketing authorization holder.

• Notification of Changes:

  • Changes to the Manufacturer: If the device is transferred to a new manufacturing site, the new manufacturer must be registered.

  • Changes to Device Characteristics: If there are significant changes to the device’s safety profile, function, or labeling (e.g., new warnings, updates to indications for use), this must be submitted as an updated application.

  • Updates to Clinical Data: If new clinical studies or post-market clinical data affect the safety or efficacy of the device, this should be incorporated into the updated registration documents.

• Periodic Safety Reports:

  • As part of the post-market surveillance system, you may be required to submit a Periodic Safety Update Report (PSUR) to the DoH. This report will summarize the safety and performance data, including any adverse events, complaints, recalls, or field corrective actions.

• Notifying Adverse Events:

  • Report any serious adverse events or incidents related to the device through the appropriate channels. If new risks are identified, this must be reported as part of your update.

3. Documentation and Evidence for Periodic Updates

The updated technical documentation should include the following:

• Updated Device Information:

  • Detailed information on the device changes, such as updates to its design, components, intended use, or labeling.

  • A revised risk management report that reflects the changes.

• Updated Clinical Data (if applicable):

  • New clinical studies, clinical performance data, or other evidence that might affect the device's safety and effectiveness.

  • Literature review or post-market data related to the device's ongoing safety profile.

• Revised Instructions for Use (IFU):

  • Any modifications or updates to the labeling or instructions for use to reflect new information, warnings, or guidelines.

• Quality Management System (QMS) Updates:

  • If the device undergoes manufacturing changes, you may need to provide evidence of an updated ISO 13485-compliant Quality Management System (QMS).

• Corrective Actions and Risk Management Updates:

  • Reports detailing corrective actions taken (e.g., recalls, design changes) as a result of post-market surveillance or adverse event analysis.

  • An updated risk management file indicating how the device's risks are being addressed.

4. Key Timelines and Intervals for Updates

• Annual Report:

  • In some cases, an annual update may be required, particularly for Class III devices, to ensure continued compliance. This report will often include a summary of post-market surveillance and product performance.

• Significant Changes:

  • If you make substantial changes to the device (such as altering its intended use, performance characteristics, or manufacturing site), you should submit an updated registration before or immediately after implementing the changes.

• Adverse Event Reporting:

  • Serious adverse events must be reported within a specified time frame, typically 15 days for serious events and 30 days for less severe incidents.

5. Key Considerations for Periodic Updates

• Stay Informed: Keep up-to-date with changes in regulatory requirements for medical devices in Hong Kong. Regularly check for updates on the Hong Kong Department of Health's website and other regulatory bodies to ensure compliance.

• Consistency and Accuracy: Ensure that all updated technical documentation, including risk assessments, clinical data, and safety reports, is complete, accurate, and consistent. Inaccurate or incomplete submissions could delay the approval of your updated registration.

• Timeliness: Submit updates as promptly as possible to avoid any gaps in the regulatory status of your device. Failure to submit updates in a timely manner could result in penalties or suspension of your registration.

• Engage with Authorized Representatives: If you are using an authorized representative (AR) in Hong Kong, ensure they are actively involved in monitoring regulatory changes and managing the update process.

6. Where to Submit Periodic Updates

• Hong Kong Department of Health (DoH): All updates related to Class III medical devices must be submitted to the Department of Health through the MDACS registration system.

• Authorized Representative (AR): If you are based outside Hong Kong, your AR can assist in submitting updates on your behalf.

7. Post-Update Confirmation

• Once the updates are submitted, the DoH will review the new documentation and either approve or request further information. Ensure that all regulatory feedback is addressed promptly to avoid delays.

• If any changes to the registration are made, you will receive an updated registration certificate confirming the validity of the updated information.

Summary of Periodic Updates Process

1. Review and Prepare: Gather documentation for any changes to the device (e.g., design, labeling, performance).

2. Submit Update: Submit the update, including necessary safety reports, clinical data, and revised technical documents to the DoH.

3. Annual Reports: Submit periodic safety reports and annual updates where required.

4. Follow Timelines: Ensure all changes are submitted promptly, particularly after significant modifications.

5. Monitor Feedback: Respond to any feedback or requests for additional information from the DoH to ensure continued registration.

By maintaining an organized system for monitoring and updating your Class III medical device’s registration, you will ensure continued compliance with Hong Kong’s regulatory framework and a smooth market presence.

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