Yes, Class II medical device MDACS registration in Hong Kong does require periodic reviews, but annual reviews specifically are not typically required. However, there are certain conditions and obligations that manufacturers or authorized representatives must follow to ensure continued compliance with the MDACS system after registration:

Key Points about Post-Registration Requirements:

1. Post-Market Surveillance:

   • Even after obtaining registration, manufacturers are responsible for ensuring their medical devices remain in compliance with safety and performance standards throughout their lifecycle. This includes post-market surveillance and the reporting of adverse events.

   • Regular monitoring of the device's safety and efficacy is required to ensure that the device continues to meet regulatory standards.

2. Notification of Changes:

   • Manufacturers must notify the Medical Device Control Office (MDCO) of any significant changes to the device or its manufacturing processes. This could include changes in design, intended use, labeling, or production methods.

   • If any of these changes are substantial, the manufacturer may need to submit updated documentation and potentially undergo another review process to ensure that the changes do not affect the device's compliance.

3. Periodic Updates:

   • Although there is no specific annual review requirement for Class II devices, periodic updates of certain documents may be required to keep the registration valid. These updates may include technical files, quality management system audits, or clinical data updates if any new relevant information becomes available.

   • The MDCO may request periodic updates to ensure that the registered device continues to comply with local regulations.

4. Inspection and Audits:

   • The Hong Kong Department of Health may carry out periodic inspections or audits to verify that manufacturers are adhering to the standards outlined in their MDACS registration. These inspections ensure continued compliance with regulatory requirements and may result in corrective actions if necessary.

5. Validity and Renewal:

   • Once a device is registered under MDACS, the registration remains valid as long as there are no significant changes to the device or its risk profile.

   • If changes occur, or if a new product is introduced, manufacturers may need to submit for an updated registration or amend the existing one.

Conclusion:

While annual reviews are not typically required for Class II medical device MDACS registration in Hong Kong, manufacturers must ensure that their devices continue to comply with regulatory requirements by maintaining an active post-market surveillance system and notifying the MDCO of any significant changes to the device. Periodic updates and inspections may be part of the process to maintain the device's registration over time.