Adverse Event Reporting
TR-005 · HK-unique timeframes
What Must Be Reported
Report any event involving an MDACS-listed device that resulted or could result in:
- Death or serious injury to patient, user, or other person
- Near-incident (potential serious harm if recurrence)
- Serious public health concern
Reporting Timeframes
| Situation | Timeframe |
|---|---|
| Death / serious injury / serious public health concern | Within 10 calendar days of LRP becoming aware |
| Other reportable/potentially reportable events | Within 30 calendar days of LRP becoming aware |
Process
- LRP becomes aware of event
- LRP investigates (with manufacturer if needed)
- Submit preliminary report to MDD within applicable timeframe
- Complete investigation → submit final report with findings and recommendations
- MDD reviews and may request further information or initiate its own investigation
Reports are submitted via the MDIS portal.
Clarify in the Reporting Timeframes section: 'The timeframes begin from the date the LRP becomes aware of the event, not from the date the event occurred. LRP awareness includes awareness through customer complaints, healthcare facility reports, or internal investigations.'