In Hong Kong, Class II in vitro diagnostic (IVD) medical devices registered under the Medical Device Administrative Control System (MDACS) are not subject to mandatory annual reviews. However, manufacturers are required to maintain ongoing compliance with regulatory standards and should be prepared for periodic audits or inspections by the authorities.

Key Points:

1. Post-Market Surveillance:

   • While annual reviews are not required, manufacturers must implement post-market surveillance systems to monitor the device’s performance and safety once it is on the market.

2. Continuous Compliance:

   • Manufacturers should continuously ensure that their products meet applicable regulatory requirements, including maintaining a quality management system (e.g., ISO 13485).

3. Changes and Amendments:

   • If there are significant changes to the device, such as modifications in design, intended use, or manufacturing processes, manufacturers are required to notify MDACS and may need to submit an amendment to the original registration.

4. Documentation Maintenance:

   • Keep all technical documentation, risk management records, and post-market surveillance data up to date for potential inspections or audits.

5. Regulatory Updates:

   • Stay informed about any updates to regulations that may affect compliance obligations.

Summary

While annual reviews are not mandated for Class II IVD registration in Hong Kong, manufacturers must maintain compliance, conduct post-market surveillance, and notify authorities of significant changes to their devices.