Incident Reporting & Vigilance
Decree 98/2021/ND-CP requires manufacturers and Authorised Representatives to report adverse incidents involving medical devices to DAV. This vigilance system is designed to detect safety signals early and protect patients.
What must be reported?β
A reportable incident is any malfunction or deterioration in the characteristics or performance of a device, or any inadequacy in labelling or instructions for use, which has led to or could lead to:
- The death of a patient, user, or third party
- A serious deterioration in the health of a patient, user, or third party (including a serious injury or serious illness requiring medical intervention)
- A potentially serious public health threat
Near-misses β events that could have resulted in the above but did not, due to fortunate circumstance or timely intervention β should also be assessed and may require reporting.
Who reports?β
| Party | Obligation |
|---|---|
| Manufacturer | Design, initiate, and manage the vigilance system; assess all complaints and adverse events; submit reports to DAV via the Authorised Representative |
| Vietnamese Authorised Representative | Submit reports to DAV via DMEC; coordinate with manufacturer on investigations |
| Importer / Distributor | Forward complaints and adverse event information to the manufacturer / Authorised Representative promptly |
| Healthcare facility | Report serious adverse events and device malfunctions to DAV (Sα» Y tαΊΏ at provincial level or DAV directly) |
Reporting timeframesβ
| Event type | Timeframe |
|---|---|
| Event resulting in death or unanticipated serious deterioration | Within 10 days of becoming aware |
| Event resulting in serious injury | Within 30 days of becoming aware |
| Trend report (increased frequency of expected events) | Within 30 days of trend analysis indicating a signal |
| Periodic summary report | Annually or as requested by DAV |
How to reportβ
Incident reports are submitted to DAV via the DMEC portal. Reports should include:
- Device identification details (name, model, registration number)
- Event description β what happened, when, where
- Patient and user information (anonymised)
- Initial assessment of cause (device, user, clinical environment)
- Immediate actions taken
- Planned investigation
DAV may request follow-up information or a final investigation report.
Investigation and follow-upβ
After submitting an initial report, the manufacturer must:
- Conduct a thorough root cause investigation
- Submit a final investigation report to DAV within the timeframe specified by DAV (typically 30β90 days)
- If the investigation identifies a systemic issue, initiate an FSCA (see FSCA & Recalls)
A robust complaint-handling system that tracks all customer complaints β not just those that are reportable β is essential for detecting trends and fulfilling PMS obligations. Many FSCAs originate from a pattern of non-reportable complaints.