Post-Market Overview
Placing a medical device on the Vietnamese market is the beginning, not the end, of your regulatory obligations. Decree 98/2021/ND-CP imposes a range of ongoing post-market requirements on manufacturers, Authorised Representatives, importers, and distributors.
Core post-market obligations
| Obligation | Who is responsible | Where to find detail |
|---|---|---|
| Incident reporting & vigilance | Manufacturer / Authorised Rep | Incident Reporting |
| Field Safety Corrective Actions (FSCA) | Manufacturer / Authorised Rep + distributor | FSCA & Recalls |
| Post-market surveillance | Manufacturer | Post-Market Surveillance |
| Labelling compliance | Manufacturer / importer | Labelling |
| Change notification | Manufacturer / Authorised Rep | Change Notification |
| Registration renewal (Type C/D) | Authorised Rep | Marketing Authorisation |
Why post-market compliance matters in Vietnam
DAV and provincial health departments conduct market surveillance activities — including inspection of importers, distributors, and healthcare facilities. Non-compliance with post-market obligations can result in:
- Suspension or revocation of the device's marketing authorisation or declaration
- Fines under Decree 117/2020 (Administrative Sanctions)
- Criminal liability in serious cases
- Loss of eligibility for public hospital procurement tenders
Roles and responsibilities
Manufacturer / foreign manufacturer
Responsible for the overall post-market system — designing PMS plans, investigating complaints, analysing safety signals, and initiating FSCAs when warranted.
Vietnamese Authorised Representative
Serves as the local point of contact for DAV. Receives safety signals from the foreign manufacturer and coordinates local regulatory actions including FSCA implementation and incident reporting to DAV.
Importer / Distributor
Responsible for GDP compliance, maintaining distribution records for traceability, cooperating with FSCAs, and forwarding complaints and adverse event reports to the manufacturer or Authorised Representative.
The DMEC portal for post-market activities
Post-market incident reports and FSCA notifications are submitted through the DMEC portal. Ensure all relevant staff have appropriate DMEC access and are trained in the reporting procedures.
→ See DMEC Portal