Post-Market Surveillance
Post-market surveillance (PMS) is the systematic process of collecting, recording, and analysing data on the safety and performance of a medical device throughout its commercial life. Under Decree 98/2021, manufacturers must maintain an active PMS system for devices on the Vietnamese market.
PMS plan
A written PMS plan must be in place before a device enters the Vietnamese market. For registered devices (Type C/D), the PMS plan is part of the registration dossier. The plan should define:
- Objectives — what safety and performance data is being monitored
- Data sources — complaint database, literature surveillance, registry data, adverse event reports, field service data
- Methods — how data will be collected, analysed, and assessed against predefined thresholds
- Responsible parties — who within the manufacturer's organisation owns each activity
- Frequency — how often PMS data is reviewed
- Escalation criteria — what signals will trigger a deeper investigation or FSCA
Data sources for PMS
| Data source | What it captures |
|---|---|
| Complaint handling system | User and healthcare facility complaints |
| Adverse event reports | Incidents reported to DAV and received from healthcare facilities |
| Literature surveillance | Published clinical and technical literature on the device type |
| Registry and outcomes data | Real-world performance data from registries (where available) |
| Field service records | Data from repair and maintenance activities |
| Regulatory database reviews | Published FSCAs and recalls from other markets |
Complaint handling
The manufacturer must maintain a formal complaint-handling procedure covering:
- Receiving and recording all complaints
- Initial triage and assessment (is this a reportable incident?)
- Investigation and root cause analysis
- Response to the complainant
- Trending and aggregate analysis
Vietnamese distributors and the Authorised Representative must forward all complaints to the manufacturer promptly.
Periodic summary reports
For Type C and D devices (registered devices), Type A and B devices (declared devices) are also subject to PMS obligations, though formal periodic reports may not be routinely requested. DAV may request a periodic safety update or PMS summary report. The report should cover:
- Complaint summary and trend analysis
- Adverse event reports submitted in the period
- Any FSCAs or field corrections conducted
- Literature updates of significance
- Overall benefit-risk conclusion
When PMS triggers further action
If PMS analysis reveals a safety signal—such as an unexpected increase in adverse events, a pattern of similar complaints suggesting a systemic issue, or published clinical evidence of a previously unrecognised risk—the manufacturer must:
- Conduct a formal risk assessment
- Update the risk management file
- If the risk is unacceptable → initiate an FSCA
- Report to DAV as appropriate