In April 2021, Hong Kong Department of Health updated the GN-03, Guidance Notes for Adverse Event Reporting by Local Responsible Persons.
Under the MDACS, the Local Responsible Persons (LRPs) are required, among other things, to report and manage adverse events happening in Hong Kong concerning their listed medical devices. This document provides guidance on the types of adverse events that should be reported by the LRPs to the Medical Device Division (MDD) and the timescales for reporting respective types of adverse events.
The updated version of the guidance notes revised the timeframes for submitting adverse event reports, and also renamed ‘Adverse Incident’ to ‘Adverse Event’.
It is a new requirement that Adverse event that has posed or likely to pose a public health risk must be reported by the LRP within 48 hours.
The other requirements remain unchanged:
- Adverse events that result in death or serious injury must be reported by the LRP to the MDD as soon as possible, but not later than 10 elapsed calendar days after the LRP becomes aware of the incident.
- All other reportable adverse events must be reported by the LRP to the MDD as soon as possible, but not later than 30 elapsed calendar days after the LRP becomes aware of the event.
- The LRP must submit a report to the MDD with as much information as possible within the required timeframe. Incomplete information is not an excuse for not meeting this requirement.
GN-03, Guidance Notes for Adverse Event Reporting by Local Responsible Persons, 2021